| Endurant AAA Stent Graft Delivers Durable Outcomes for Abdominal Aortic Aneurysm Repair |
Three-Year Clinical Data Presented at Annual Meeting of Society for Vascular Surgery Reaffirms Physician Confidence in Market-Leading Endovascular Device
SAN FRANCISCO -- May 31, 2013 -- The Endurant AAA stent graft system from Medtronic, Inc. (NYSE: MDT) continues to distinguish itself, with new data on the market-leading device for the endovascular repair of abdominal aortic aneurysms demonstrating durable clinical performance through three years of patient follow-up.
Presented at the Society for Vascular Surgery's "Vascular Annual Meeting," the three-year data comes from the clinical study that contributed to the device's approval by the U.S. Food and Drug Administration (FDA) in Dec. 2010. The data show 100 percent freedom from aneurysm-related mortality, 0 percent post-implant aneurysm rupture, 0 percent stent graft migration and 0 percent conversion to open repair for the 107 patients followed to three years.
"It's particularly compelling to review this mid-term data on the Endurant system, which delivers sustained clinical performance across key endpoints at three years," said Dr. William Jordan Jr., professor of surgery and chief of vascular surgery and endovascular therapy at the University of Alabama Birmingham. "The robust outcomes seen in the U.S. study confirm the durability of the Endurant stent graft."
Under an investigational device exemption (IDE) granted by the FDA, the study enrolled 150 patients at 26 U.S. medical centers and continues to chart the Endurant stent graft's strong performance in the endovascular repair of abdominal aortic aneurysms. The rate of freedom from secondary endovascular procedures to the three-year time-point was 91.5 percent; and compared to baseline, 95.4 percent of the aneurysm sacs were either the same size or had decreased in diameter by at least 5mm at three years. Only one patient in the study had a Type I/III endoleak at three years.
Chosen for nearly one out of every two endovascular abdominal aortic aneurysm repairs worldwide, the Endurant system has been used to treat more than 100,000 patients, a milestone achieved in the spring of 2013-less than five years after the device's initial launch: the original Endurant AAA stent graft received the CE (Conformité Européene) Mark in July 2008. The next-generation Endurant II system is now available in more than 100 countries around the world
In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology-alleviating pain, restoring health and extending life for millions of people around the world. |
Friday, May 31, 2013
Endurant AAA Stent Graft Delivers Durable Outcomes for Abdominal Aortic Aneurysm Repair
Medtronic News Release:
Lucentis® receives positive opinion for patients with myopic choroidal neovascularization showing vision gains with only two injections
Novartis Media Release:
May 31, 2013 13:21 CET
Lucentis® receives positive opinion for patients with myopic choroidal neovascularization showing vision gains with only two injections
- Lucentis recommended for approval in EU to treat patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia
- Lucentis superior to current standard of care and improves mean visual acuity by around 14 letters at one year with a median of a total of two injections
- Untreated, 90 % of patients with myopic choroidal neovascularization suffer severe visual loss
Basel, May 31, 2013 - Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Lucentis® (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV).
CNV is the most common vision-threatening complication of high myopia[1]. Myopic CNV usually affects patients younger than 50 years old so any associated vision loss can have not only a significant impact on their quality of life but also on their productivity and to society[2]. In patients with untreated myopic CNV the long-term prognosis is poor with approximately 90% of affected patients developing severe vision loss after five years[3].
"Lucentis has already transformed the management of wet AMD, and we are very hopeful that if Lucentis receives approval in a fourth major ocular indication that patients with myopic CNV will benefit from this medicine," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "Currently, all we hope to do for these patients is to stabilize vision and prevent further vision loss, so a treatment with the long-term safety profile of Lucentis that actually improves and maintains vision with just a few injections would be of great benefit."
The submission was supported by data from the Novartis-sponsored clinical trial, RADIANCE, that showed Lucentis provides superior improvement in visual acuity compared with the current licensed standard of care, Visudyne® (verteporfin PDT), in patients with myopic CNV. These new data showed around 40% of Lucentis treated patients compared with 15% of Visudyne treated patients gained 15 or more letters of visual acuity at month three[4]. Mean visual acuity gains of approximately 14 letters at one year were demonstrated with Lucentis; this was with a median of 2.0 injections.
In this pivotal Phase III study patients were randomized to one of three treatment arms: Lucentis treatment based on visual acuity stability (group 1) or disease activity (group 2); or Visudyne treatment (group 3). Subjects randomized to Visudyne could be given Lucentis after three months based on persistent disease activity. The primary endpoint was Lucentis superiority to Visudyne based on the mean visual acuity change from baseline to month three. Patients were followed for twelve months.
Both the Lucentis treatment groups were statistically superior (p<0.00001) to the Visudyne treatment group. Mean letter gains at month three from baseline in the two Lucentis groups (groups 1 and 2) were 12.1 and 12.5 letters, respectively, compared to a 1.4 letter gain in the Visudyne treatment arm (group 3). At twelve months, the mean letter gains from baseline were 13.8 (group 1), 14.4 (group 2) and 9.3 (group 3).
The safety profile of Lucentis was consistent with that observed in other studies as well as real-world experience and no new ocular/non-ocular safety risks were identified. The most common adverse events occurring in more than ten percent of patients, at twelve months, were conjunctival hemorrhage (ocular) and nasopharyngitis (non-ocular).
About Lucentis® (ranibizumab)
Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A). Increased levels of VEGF-A are seen in wet AMD and other ocular diseases such as diabetic macular edema (DME) and retinal vein occlusion (RVO). Lucentis was specifically designed for the eye, minimizing systemic exposure.
Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A). Increased levels of VEGF-A are seen in wet AMD and other ocular diseases such as diabetic macular edema (DME) and retinal vein occlusion (RVO). Lucentis was specifically designed for the eye, minimizing systemic exposure.
Lucentis is licensed for the treatment of wet AMD in more than 100 countries, in more than 90 countries for the treatment of visual impairment due to DME and in 90 countries for visual impairment due to macular edema secondary to RVO, including both branch- and central-RVO. In many countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.
Lucentis has a well-established safety profile supported by 43 extensive sponsored clinical studies and real-world experience. Its safety profile has been well established in a clinical development program that enrolled more than 12,500 patients across indications and there is more than 1.7 million patient-treatment years of exposure since its launch in the United States in 2006.
Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.
Novartis sponsors the eXcellence in Ophthalmology Vision Award (XOVA). XOVA is an annual award launched in 2010 that provides funding to non-profit initiatives and projects that will have a positive impact on improving the quality of eye care and make a significant impact in addressing unmet needs in the fields of ophthalmology and optometry.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "recommended," "hopeful," "will," "hope," "would be," "could," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Lucentis or regarding potential future revenues from Lucentis. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Lucentis to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Lucentis will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Lucentis will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Lucentis could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
The foregoing release contains forward-looking statements that can be identified by terminology such as "recommended," "hopeful," "will," "hope," "would be," "could," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Lucentis or regarding potential future revenues from Lucentis. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Lucentis to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Lucentis will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Lucentis will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Lucentis could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 129,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visithttp://www.novartis.com.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 129,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visithttp://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.
References
1. Neelam K et al. Choroidal neovascularization in pathological myopia. Prog Retin Eye Res 2012;31:495-525.
2. Rose K et al. Quality of life in myopia. Br J Ophthalmol 2000;84:1031-1034.
3. Yoshida T et al. Myopic choroidal neovascularization: a 10-year follow-up. Ophthalmology 2003;110:1297-1305.
4. Wolf S et al. Ranibizumab vs verteporfin PDT for choroidal neovascularization secondary to pathologic myopia: a Phase III study. Asia Pacific Academy of Ophthalmology 2013.
1. Neelam K et al. Choroidal neovascularization in pathological myopia. Prog Retin Eye Res 2012;31:495-525.
2. Rose K et al. Quality of life in myopia. Br J Ophthalmol 2000;84:1031-1034.
3. Yoshida T et al. Myopic choroidal neovascularization: a 10-year follow-up. Ophthalmology 2003;110:1297-1305.
4. Wolf S et al. Ranibizumab vs verteporfin PDT for choroidal neovascularization secondary to pathologic myopia: a Phase III study. Asia Pacific Academy of Ophthalmology 2013.
# # #
GE Healthcare Announces Commercial Availability of New Methodology That Provides a Cancer Profile on a Single Slide
GE Press Release:
GE Healthcare Announces Commercial Availability of New Methodology That Provides a Cancer Profile on a Single Slide
May 31, 2013
--Groundbreaking method uses quantitative protein analysis to identify new biosignatures, for personalized treatments--
PRINCETON, NJ, May 31, 2013 – GE Healthcare today announced at the 2013 Annual Meeting of the American Society of Clinical Oncology its plans for the commercialization of MultiOmyx™, a ground-breaking new pathology platform, using proprietary methodology to analyze multiple proteins at a single-cell level. Traditional pathology uses multiple slices from paraffin-fixed tumor samples and examines them slide by slide, which is less efficient and effective. The platform, already in use in research, will now be introduced to the clinical environment and initially available for testing through a global service offering in Hodgkin lymphoma in July 2013 in GE Healthcare’s CLIA licensed laboratory – Clarient Diagnostic Services, Inc. – a GE Healthcare Company.
MultiOmyx will enable pathologists to view multiple stains on a single tumor slice, and analyze the results at a single cell level. MultiOmyx, originally developed by GE Healthcare’s Global Research Center, will be made available commercially by Clarient. The platform uses fluorescence to provide quantitative analysis of tumor antibodies and allows for more than 175 proteins to be examined on a single tissue sample.
“MultiOmyx opens up new possibilities for cancer research and development of innovative cancer prognostics and differential diagnostics,” said Carrie Eglinton Manner, CEO, Clarient. “Using a single slide saves time, uses significantly less tissue and provides a far more consistent result. Since different parts of a tumor sample can act differently and because less tissue is required, pathologists can access the most accurate and broad tumor analysis available, while eliminating today’s need to prioritize tests due to limited tissue availability.”
The automated technology creates a “digital map” of the tumor, giving each cell an “address” and allowing for a clear graphic representation of protein expression. Matching this map to known biosignatures, or clinical information, gives researchers and pathologists a more accurate representation of the exact characteristics of the tumor and provides clinicians with a clearer view to the diagnosis. It also allows them to identify patterns in the tissue by analyzing each cell and biomarker individually, or as a cluster, and thus get a level of understanding of the biological process that could not be achieved via traditional immunohistochemistry process.
“In many instances, suspected Hodgkin lymphoma cases are not straightforward, and sample tissue size inadequacy issues further complicate the matter,” said Lawrence Weiss, MD, Medical Director of Clarient. “Clarient utilized the innovative platform of MultiOmyx and developed a methodology to assess a set of markers on a single tissue section, identifying the level of expression of these markers on the very same cells, as opposed to working with serial sections which each contain different cells. In difficult to call diagnoses, MultiOmyx gives me great confidence in making the diagnosis and relieves me from the concern of running out of tissue. If I only have a small amount of tissue, I do not have to sacrifice or choose between important markers – I can assess them all.”
“If we can have a much deeper understanding of what we see in a tumor, on a slide, region of interest or at a cellular level we can make references to known characteristics – metastasis, mortality, response to therapy and others – allowing for better guide programs of care and treatments for patients,” added Eglinton Manner.
Clarient Diagnostic Services, Inc., acquired by GE Healthcare in December, 2010, combines innovative diagnostic technologies with world class pathology expertise to assess cancer. Clarient is a leading provider of diagnostic laboratory services, such as flow cytometry and molecular testing, and develops and markets new, proprietary diagnostic assays for therapeutics for breast, prostate, lung, ovarian, and colon cancers, and leukemia/lymphoma. Clarient also develops and validates new assays for its customers, speeding their use in the broader clinical setting.
Cancer is one of the leading causes of death in the world. At GE, we envision a day when cancer is no longer a deadly disease. Today’s announcement reinforces our commitment to fight cancer and reflects our current integrated portfolio and GE Healthcare’s $1B R&D investment to advance oncology solutions by 2016. In parallel, GE's Healthymagination commitment is aimed at accelerating cancer innovation and improving care for 10 million cancer patients around the world by 2020. These commitments uniquely position GE to drive game-changing impact in oncology and a leap forward for individualized cancer care.
About GE Global Research
GE Global Research is one of the world's most diversified industrial research organizations, providing innovative technology for all of GE's businesses. Global Research has been the cornerstone of GE technology for more than 100 years, and is now focused on developing breakthrough innovations in areas such as molecular medicine, alternative energy, nanotechnology, advanced propulsion, and security technologies. GE Global Research is headquartered in Niskayuna, N.Y. and has facilities in Bangalore, India; Shanghai, China; and Munich, Germany. Visit Global Research at www.ge.com/research.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
For our latest news, please visit http://newsroom.gehealthcare.com
About Clarient Diagnostic Services, Inc. Clarient Diagnostic Services, Inc. is a leading provider of comprehensive, cancer–diagnostic laboratory services. With its advanced technologies, Clarient is able to provide pathologists and oncologist with more accurate and detailed information to better characterize and assess cancer which can lead to more accurate diagnoses and more effective treatment. In addition, Clarient’s services are finding more efficient ways to reduce the cost as well as accelerating the drug development process to identify and develop treating pharmaceuticals that can result in better outcomes for patients.
From its state-of-the-art diagnostic laboratory to its Internet-based PATHSiTE®, Clarient delivers advanced oncology diagnostic services to pathologists, oncologists, hospitals and biopharmaceutical companies throughout the U.S. Clarient also is developing proprietary companion diagnostic tests for therapeutics in breast, prostate, lung and colon cancers, as well as leukemia/lymphoma.
Clarient is improving the lives of those affected by cancer by bringing clarity to a complex disease.
For more information visit www.clarientinc.com.
GE Healthcare Showcases Oncology Solution Aiding the Fight Against Cancer
GE Press Release:
GE Healthcare Showcases Oncology Solution Aiding the Fight Against Cancer
May 31, 2013
Advanced Breast Imaging Technology Highlighted at ASCO 2013
As part of its ongoing commitment to accelerating cancer innovation and assembling tools to fight cancer, GE Healthcare (NYSE: GE) will highlight the benefits of GE’s established oncology portfolio for patients across the world at ASCO 2013. During the annual meeting, which brings together the oncology community to focus on “Building Bridges to Conquer Cancer,” GE will feature imaging solutions including SenoBright* Contrast Enhanced Spectral Mammography (CESM) which has the potential to aid in the improvement of outcomes in breast cancer.
SenoBright* Contrast Enhanced Spectral Mammography (CESM)
Launched in 2010, and available worldwide, the innovative SenoBright* Contrast Enhanced Spectral Mammography (CESM) helps expedite the diagnosis of breast cancer using GE’s latest developments in digital mammography. SenoBright uses X-rays at multiple energies to create two separate but nearly simultaneous exposures; which results in images specifically highlighting contrast agent uptake in less than 10 minutes. To date, there are more than a hundred breast cancer facilities equipped with CESM globally with nearly a quarter of them in the USA.
Mammography is the standard in breast cancer screening, delivering proven clinical outcomes. However, the sensitivity and specificity of mammography images can be impacted by a range of factors that are not always visible on regular X-ray, sometimes leading to misdiagnosis. SenoBright helps radiologists localize known or suspected lesions using a unique imaging method that combines digital mammography, low-and high-energy X-rays and a contrast agent used to highlight lesions through contrast visualization.
When an inconclusive mammogram and ultrasound require further testing, scheduling and completing further diagnostic work-up - such as MRI - often creates a circuitous and lengthy path that may increase the patient’s anxiety considerably causing long-term psycho-social negative consequences even if the diagnosis rules out cancer (1). CESM shortens the path to detection, diagnosis and treatment for many patients by up to 30 days, in several ways:
(1) a CESM exam takes only 10 minutes, a little longer than a regular diagnostic mammogram, and uses the same equipment as a routine mammogram, which patients are already familiar with; it is potentially accessible in every center already equipped with a GE Senographe* DS or Essential, more than 6,000 sites worldwide;
(2) the CESM technology helps localize lesions while hiding healthy tissue, thus clarifying ambiguity of initial images;
(3) unlike MRI, CESM is not confounded by hormone replacement or menstrual cycles, so CESM can be scheduled immediately with results available within minutes, even on patients with metallic implant and pace-makers; and
(4) compared to MRI, CESM does not cause as much discomfort and is four times faster. The exam is simple: after an intravenous injection of contrast agent (similar to MRI), the patient receives a mammogram using CESM technology, which analyzes blood flow patterns within the breast tissue to help localize a known or suspected lesion.
Even if further exams are needed after CESM procedures, the time to provide a diagnosis and treatment plan to the patient can be significantly shortened.
“The insights gained through SenoBright aides physicians in diagnosis and treatment. More importantly it can improve patient experience by reducing turnaround time and the necessity of more invasive procedures. Over 5,000 patients globally have been imaged with SenoBright to date. This can result in less burden on the patient, more clinical confidence in disease classifications and has lowered the need for further interventional biopsies,” said Prahlad Singh, General Manager, Women’s Health, GE Healthcare - Detection & Guidance Solutions.
Singh added: “Since 1965, GE Healthcare has made significant progress in providing solutions for breast cancer detection and diagnosis that really bring a change into people’s lives and has committed to invest $1 billion in oncology R&D by 2016 to bring new products into the market.”
In the United States, the Pink Lotus Breast Center (pinklotusbreastcenter.com), a comprehensive and integrative breast center exclusively dedicated to the prevention, screening, diagnosis and treatment of breast cancer unveiled in May 2012, uses GE Healthcare’s Contrast Enhanced Spectral Mammography technology at its flagship breast center in Los Angeles. CESM is provided at the facility's Sheryl Crow Imaging Center - the first facility in the country to make this new advancement available to patients.
“At GE Healthcare there is a huge sense of pride as our company, through our diverse portfolio offerings, helps touch many people and save many lives. Within our Women’s Health division our goal is to continue investing in R&D in order to provide innovative solutions that will better enable clinicians to diagnose diseases earlier thereby helping patients and their families. Our #GetFIT campaigns also aim to educate employees and the general public on healthy living as we believe prevention is half the battle,” concluded Singh.
GE also launched a US$100 million Open Innovation Challenge globally to find and fund ideas to accelerate the detection of breast cancer.
GE Healthcare:
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.
Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. www.gehealthcare.com.
As part of its ongoing commitment to accelerating cancer innovation and assembling tools to fight cancer, GE Healthcare (NYSE: GE) will highlight the benefits of GE’s established oncology portfolio for patients across the world at ASCO 2013. During the annual meeting, which brings together the oncology community to focus on “Building Bridges to Conquer Cancer,” GE will feature imaging solutions including SenoBright* Contrast Enhanced Spectral Mammography (CESM) which has the potential to aid in the improvement of outcomes in breast cancer.
SenoBright* Contrast Enhanced Spectral Mammography (CESM)
Launched in 2010, and available worldwide, the innovative SenoBright* Contrast Enhanced Spectral Mammography (CESM) helps expedite the diagnosis of breast cancer using GE’s latest developments in digital mammography. SenoBright uses X-rays at multiple energies to create two separate but nearly simultaneous exposures; which results in images specifically highlighting contrast agent uptake in less than 10 minutes. To date, there are more than a hundred breast cancer facilities equipped with CESM globally with nearly a quarter of them in the USA.
Mammography is the standard in breast cancer screening, delivering proven clinical outcomes. However, the sensitivity and specificity of mammography images can be impacted by a range of factors that are not always visible on regular X-ray, sometimes leading to misdiagnosis. SenoBright helps radiologists localize known or suspected lesions using a unique imaging method that combines digital mammography, low-and high-energy X-rays and a contrast agent used to highlight lesions through contrast visualization.
When an inconclusive mammogram and ultrasound require further testing, scheduling and completing further diagnostic work-up - such as MRI - often creates a circuitous and lengthy path that may increase the patient’s anxiety considerably causing long-term psycho-social negative consequences even if the diagnosis rules out cancer (1). CESM shortens the path to detection, diagnosis and treatment for many patients by up to 30 days, in several ways:
(1) a CESM exam takes only 10 minutes, a little longer than a regular diagnostic mammogram, and uses the same equipment as a routine mammogram, which patients are already familiar with; it is potentially accessible in every center already equipped with a GE Senographe* DS or Essential, more than 6,000 sites worldwide;
(2) the CESM technology helps localize lesions while hiding healthy tissue, thus clarifying ambiguity of initial images;
(3) unlike MRI, CESM is not confounded by hormone replacement or menstrual cycles, so CESM can be scheduled immediately with results available within minutes, even on patients with metallic implant and pace-makers; and
(4) compared to MRI, CESM does not cause as much discomfort and is four times faster. The exam is simple: after an intravenous injection of contrast agent (similar to MRI), the patient receives a mammogram using CESM technology, which analyzes blood flow patterns within the breast tissue to help localize a known or suspected lesion.
Even if further exams are needed after CESM procedures, the time to provide a diagnosis and treatment plan to the patient can be significantly shortened.
“The insights gained through SenoBright aides physicians in diagnosis and treatment. More importantly it can improve patient experience by reducing turnaround time and the necessity of more invasive procedures. Over 5,000 patients globally have been imaged with SenoBright to date. This can result in less burden on the patient, more clinical confidence in disease classifications and has lowered the need for further interventional biopsies,” said Prahlad Singh, General Manager, Women’s Health, GE Healthcare - Detection & Guidance Solutions.
Singh added: “Since 1965, GE Healthcare has made significant progress in providing solutions for breast cancer detection and diagnosis that really bring a change into people’s lives and has committed to invest $1 billion in oncology R&D by 2016 to bring new products into the market.”
In the United States, the Pink Lotus Breast Center (pinklotusbreastcenter.com), a comprehensive and integrative breast center exclusively dedicated to the prevention, screening, diagnosis and treatment of breast cancer unveiled in May 2012, uses GE Healthcare’s Contrast Enhanced Spectral Mammography technology at its flagship breast center in Los Angeles. CESM is provided at the facility's Sheryl Crow Imaging Center - the first facility in the country to make this new advancement available to patients.
“At GE Healthcare there is a huge sense of pride as our company, through our diverse portfolio offerings, helps touch many people and save many lives. Within our Women’s Health division our goal is to continue investing in R&D in order to provide innovative solutions that will better enable clinicians to diagnose diseases earlier thereby helping patients and their families. Our #GetFIT campaigns also aim to educate employees and the general public on healthy living as we believe prevention is half the battle,” concluded Singh.
GE also launched a US$100 million Open Innovation Challenge globally to find and fund ideas to accelerate the detection of breast cancer.
GE Healthcare:
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.
Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. www.gehealthcare.com.
GE Technology to Provide Flexible Power for 104-Megawatt Combined-Cycle Power Plant in Italy
GE Press Release:
GE Technology to Provide Flexible Power for 104-Megawatt Combined-Cycle Power Plant in Italy
May 31, 2013
- GE’s Aeroderivative Technology Helps Fill the Gap between Base-Load Large Power Plants and Renewable Power Generation with Flexible Power Generation
- Operational Flexibility, Efficiency and Reliability are the Key Reasons Tamarete Energia Selected GE’s Proven Technology
- Project Will Help Balance the Grid Variability Associated with Wind and Solar Power Generation
- GE Teamed up with STC SpA for Seven Big Power Plant Projects in 12 Years
ORTONA, ITALY—May 31, 2013—GE’s (NYSE: GE) aeroderivative gas turbine technology has been installed at Tamarete Energia’s new, 104-megawatt combined-cycle plant near Ortona, Italy. The plant will generate enough power for approximately 34,500 Italian homes. GE’s flexible gas turbine technology, which easily helps integrate wind and solar energy into the grid, will allow the new plant to generate high-efficiency and environmentally friendly electrical power, balancing the reduction of contribution from wind and solar generation.
Tamarete Energia celebrated the opening of the plant with a ceremony held at the site today. The plant is located in the province of Chieti in Abruzzo. Tamerete Energia is a special purpose company owned by BKW Italia SpA, HERA SpA, and Odoardo Zecca S.r.l.
“Under the European Union’s 20-20-20 initiative, the use of renewable energy has increased throughout Italy, and wind and solar power has been growing rapidly,” said Patrizio Prunecchi, GE aero products commercial operations leader, EMEA for GE Power & Water. “Our flexible, high-efficiency technology can rapidly ramp up when the wind is not blowing or the sun is not shining and efficiently ramp down when they are available. As the need for electricity fluctuates throughout the day, with higher demand in the mornings when consumers are waking up and late in the afternoons when they get home from work, this allows our customers to respond to these fluctuations while enabling them to integrate more renewables across the power grid.”
Under the terms of the approximately $30 million-euro project, GE provided two LM6000-PD aeroderivative gas turbine generator packages and one 8-11 MC9 impulse-type, geared steam turbine-generator to STC SpA (Forli’, Italy). STC SpA is the Italian company selected by Tamerete Energia as the engineering, procurement and construction contractor for the combined-cycle plant.
“The Tamerete Energia power plant project is the latest in a long series of high-efficiency combined-cycle power plants that GE and STC have collaborated on over the last 12 years in all different industries from paper mills to food and beverage to chemical industries,” said Pietro Marco Stella, president of STC SpA. “We continue to work with GE based on its proven record of providing flexible and highly efficient technology that best meets our customers’ needs.”
GE’s LM6000 aeroderivative technology provides greater flexibility through its fast-start capability (10 minutes from cold iron), daily/multiple startups with no impact on the equipment maintenance cost and through its low turndown level (approximately 25 percent of power plant capacity).
“High operational flexibility, efficiency and reliability are essential to ensure economic success in Italy’s diverse power segment. GE’s technology allows us to experience less wear and tear on our components, a longer equipment lifespan and low maintenance costs because it enables flexible operation,” said Roberto Barbano, CEO of Tamerete Energia. “This type of flexible power generation helps to better meet the needs of the grid with stable, reliable energy.”
GE’s aeroderivative gas engine technology is part of the company’s portfolio of innovative distributed power solutions, designed to give businesses and communities around the world the ability to generate more reliable and efficient power using a variety of fuels in diverse locations on or off the grid. GE’s distributed power portfolio includes Jenbacher and Waukesha gas engines and Clean Cycle waste heat recovery solutions.
About GE
GE (NYSE: GE) works on things that matter. The best people and the best technologies taking on the toughest challenges. Finding solutions in energy, health and home, transportation and finance. Building, powering, moving and curing the world. Not just imagining. Doing. GE works. For more information, visit the company's website at www.ge.com.
About GE Power & Water
GE Power & Water provides customers with a broad array of power generation, energy delivery and water process technologies to solve their challenges locally. Power & Water works in all areas of the energy industry including renewable resources such as wind and solar, biogas and alternative fuels; and coal, oil, natural gas and nuclear energy. The business also develops advanced technologies to help solve the world’s most complex challenges related to water availability and quality. Power & Water’s six business units include Distributed Power, Nuclear Energy, Power Generation Services, Renewable Energy, Thermal Products and Water & Process Technologies. Headquartered in Schenectady, N.Y., Power & Water is GE’s largest industrial business.
Follow GE Power & Water on Twitter @GE_PowerWater.
GE Healthcare Introduces Predictive Analytics, Customizable Shared Services Solutions for Clinical Engineering Departments
GE Press Release:
GE Healthcare Introduces Predictive Analytics, Customizable Shared Services Solutions for Clinical Engineering Departments
May 31, 2013
OnWatch for Clinical Networks and AssurePoint In-House Access enable in-house departments to deliver more productive and cost-effective service without outsourcing
Waukesha, Wis. - May 31, 2013 - GE Healthcare, a division of General Electric Company (NYSE:GE), will introduce and demonstrate its newest tools to help in-house clinical engineering teams deliver more cost-effective, productive service at the AAMI 2013 Conference & Expo taking place June 1-3, 2013 in Long Beach, California.
In-house clinical engineers play an increasingly vital role in patient care as the volume of clinical devices at a patients’ bedside and the size of the networks that support them continue to grow. To meet the evolving needs of in-house departments, GE Healthcare has developed a flexible portfolio of service features and informatics that provide swift access to GE’s expertise and support.
“In-house clinical engineers have taken on increasingly critical and demanding role in today’s hospitals, and are under greater budgetary pressures than ever,” said Richard Neff, Vice President of US and Canada Service. “At GE Healthcare, we are committed to collaborating with members of the in-house biomedical community to help them tackle these challenges while maintaining the level of service that is critical for patient care.”
At AAMI 2013, GE Healthcare will introduce OnWatch for Clinical Networks—a new application of GE’s predictive analytics OnWatch technology that enables biomedical engineers to continuously monitor medical equipment and receive alerts any time there is an outage, device malfunction, or intrusion within a clinical network. Leveraging this web application-based system, in-house teams can identify and resolve service issues before they lead to crises, and minimize unplanned downtime and the need for urgent maintenance events. Specifically, OnWatch for Clinical Networks gives in-house teams the ability to:
- View which specific devices on the network have technical abnormalities when benchmarked against other network devices.
- View a complete report of each network devices’ service history, which is helpful in detecting “problem” devices.
- Isolate equipment malfunctions and help to shut down parts of the network in a controlled manner when needed.
- Remotely monitor and access network devices from any location with an IP connection.
GE Healthcare will also highlight AssurePoint In-House Access—an integrated, customizable solution where GE collaborates with in-house clinical engineering teams to help further their goals of increasing productivity and asset availability and lowering administrative costs. Key features include:
- Parts Ordering & Management: Helps teams eliminate hours spent chasing suppliers
- Training Module: Cost effective access to online technical and EHS training programs and competency assessments
- Accreditation Readiness: Enables teams to test the readiness of equipment management program for Centers for Medicaid and Medicare (CMS), The Joint Commission (TJC), Det Norske Veritas (DNV), and Code of Federal Regulations (CFR) compliance.
- Test Equipment Calibration: Helps provide teams with necessary calibrations to test equipment as needed
- Physical Inventory: Provides teams tools, including barcodes, to generate a complete and accurate inventory of all clinical assets.
To learn more about GE Healthcare’s latest offerings for in-house biomedical engineers at the AAMI 2013 Conference & Expo, visit GE Booth #103 at the Long Beach Convention Center.
Contact Information
- Name
- Holly Langdon
- Job Title
- PR Manager
- Division
- GE Healthcare
- Phone
- 1-414-721-3353
- Mobile
- 1-414-429-6998
- holly.langdon@ge.com
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.
Our “healthymagination” vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website atwww.gehealthcare.com.
For our latest news, please visit http://newsroom.gehealthcare.com/http://newsroom.gehealthcare.com
GE Capital and Element Financial Establish Strategic Cross Border Fleet Services Alliance
GE Press Release:
GE Capital and Element Financial Establish Strategic Cross Border Fleet Services Alliance
May 31, 2013
Norwalk, Connecticut & Toronto, Ontario, May 31, 2013 - Element Financial Corporation (TSX:EFN) (“Element” ) and GE Capital (“GE Capital”) announced today that they have entered into a definitive asset purchase agreement (the “Agreement”) whereby Element acquires GE Capital’s Canadian fleet portfolio and the two companies form a strategic alliance to deliver comprehensive vehicle fleet financing and management services to cross-border customers in Canada and the United States.
Under the terms of the Agreement, Element will acquire GE Capital’s existing Canadian fleet portfolio for consideration of C$570 million (the “Acquisition Transaction”) subject to adjustments, along with the GE Capital Canada fleet operational resources required to service this portfolio. These Canadian operations will be combined with TLS Fleet Management, Element’s existing fleet management business.
In addition to serving the domestic Canadian fleet industry, the combined entity operating under the Element Fleet Management brand will serve Canadian customers under a Strategic Alliance Agreement (the “Strategic Alliance”) between Element and GE Capital Fleet Services. Through the long-term Strategic Alliance, the two companies will jointly pursue Canada/US cross-border fleet management opportunities.
“This alliance with GE Capital Fleet Services enables Element Fleet to bring more comprehensive fleet management technologies and solutions to our existing customers at the same time that it expands our addressable client base by giving us the capacity to deliver fleet management services to customers with needs on both sides of the Canada/US border,” said Steven K. Hudson, Element’s Chairman and Chief Executive Officer.
“This strategic alliance creates significant advantages for our GE Capital Fleet Services customers operating fleets in Canada,” said Kristi Webb, President and CEO of GE Capital Fleet Services. “Our customers will enjoy a broader range of services, more geographic coverage and more feet on the ground in rapidly growing Canadian markets, and diversified capital funding sources to support their fleet needs.”
Kathy Lee, President and CEO of GE Capital Canada, said: "We are pleased to announce this alliance with Element Fleet Management and we would like to take this opportunity to acknowledge the employees’ great work in serving GE Capital Canadian Fleet customers for so many years. This alliance will give our customers the benefit of access to the services and network of one of the most respected fleet management companies in Canada.”
The Agreement provides for customary closing conditions, including approval under the Competition Act (Canada). Subject to the satisfaction of such conditions, the Acquisition Transaction is expected to close on or about June 28, 2013.
Scotiabank acted as financial advisor to GE Capital in connection with the Transaction. McCarthy Tétrault LLP acted as legal counsel to GE Capital. GMP Securities L.P., BMO Capital Markets and Barclays Capital Inc. acted as financial advisors to Element in connection with the Transaction. Blake, Cassels & Graydon LLP acted as legal counsel to Element.
About Element Financial Corporation
With total assets of approximately C$1.77 billion, Element Financial Corporation is one of North America’s leading independent equipment finance companies. Element operates across North America in three verticals of the equipment finance market - Element Capital provides large ticket equipment leasing, Element Finance serves the mid-ticket equipment finance market and Element Fleet provides vehicle fleet leasing and management solutions through the Company’s TLS Fleet Management division.
About GE Capital Fleet Services
GE Capital Fleet Services, based in Eden Prairie, Minn., is a global fleet leasing and management company with strong capital resources, unmatched data and analytics and deep strategic consulting capabilities to help organizations find new ways to optimize their investments throughout the fleet lifecycle. Visit our web site atwww.gefleet.com or follow the company’s eco news and updates via Twitter (@GEFleetSvcs).
About GE Capital
For almost 30 years, GE Capital has been in Canada, providing leasing and lending to mid-market companies. GE Capital is one of the world’s largest providers of credit and expertise. For more than one million businesses, GE Capital provides financing to purchase, lease and distribute equipment, as well as capital for real estate and corporate acquisitions, refinancings and restructurings. GE Capital is a leader in a number of industries, from airlines, healthcare and energy financing to fleet, franchise and middle market corporate finance. For approximately 80 million consumers, GE Capital offers credit cards and retail sales finance programs. GE Capital is an extension of GE's rich heritage of building and supporting growth, providing customers with insight, knowledge and expertise in addition to financing.
General Dynamics NASSCO to Construct Four Product Tankers for American Petroleum Tankers
General Dynamics Press Release:
May 31, 2013
May 31, 2013
General Dynamics NASSCO to Construct Four Product Tankers for American Petroleum Tankers
PLYMOUTH MEETING, Penn., and SAN DIEGO – General Dynamics NASSCO, a wholly owned subsidiary of General Dynamics (NYSE: GD), announced today that it has entered into a contract with an affiliate of American Petroleum Tankers (APT), a company majority owned by funds managed by Blackstone on behalf of its investors, for the design and construction of four 50,000 deadweight ton LNG-conversion-ready product carriers with a 330,000 barrel cargo capacity. The contract includes options to build four additional ships.
Construction of the first tanker is scheduled to begin in the third quarter of 2014, with deliveries scheduled to begin in the fourth quarter of 2015, continuing through 2016. The four-ship APT contract will add up to approximately 800 jobs at NASSCO during construction and more than 165 seagoing union jobs during the operation of the vessels.
The 610-foot-long tankers are a new “ECO” design that offers improved fuel efficiency and incorporates the latest environmental protection features, including a Ballast Water Treatment System. All of the ECO-class tankers will be constructed at the NASSCO shipyard in San Diego. This contract builds upon the strong relationship NASSCO and APT developed during the construction of five State-class product carriers from 2007 to 2010.
The ships will be designed by DSEC, a subsidiary of Daewoo Shipbuilding & Marine Engineering (DSME) of Busan, South Korea. DSEC’s ECO design achieves improved fuel efficiency through several features, including a G-series MAN ME slow-speed main engine and an optimized hull form. The tankers will have dual-fuel-capable auxiliary engines and the ability to accommodate future installation of an LNG fuel-gas system. The ECO-class tankers represent the continuation of NASSCO’s successful partnership with DSEC, which was a partner on the five APT State-class product tankers and currently is contributing to two LNG-powered containerships for TOTE Shipholdings, Inc.
Fred Harris, President of General Dynamics NASSCO, said, “By continuing to bring the most economical and environmentally sound technology to Jones Act operators, these ECO tankers show our continued commitment to be one of the most innovative shipyards in America. I am pleased to renew our partnership with APT on this exciting new program. Along with TOTE, this is the second return customer we have welcomed back to NASSCO within the past six months, which speaks to the high-quality workmanship of our skilled workforce.”
The construction and operation of the new vessels are aligned with the Jones Act, which requires that ships carrying cargo between U.S. ports be built in U.S. shipyards.
Rob Kurz, CEO of APT, said, “This investment demonstrates our continued commitment to building and operating ships for the U.S. Jones Act trade. We are proud to bring new U.S.-built tonnage into the market at this exciting time, helping our country achieve its long-standing strategic objective of energy independence."
Sean Klimczak, Senior Managing Director of Blackstone, said, “This investment demonstrates our long-standing support of the U.S. maritime industry and our commitment to bolstering job creation in the U.S. We are pleased to partner again with NASSCO on this important newbuild program and to provide growth equity to APT to construct and bring these new, state-of-the-art vessels to market.”
For more information about General Dynamics NASSCO, please visit www.nassco.com. More information about General Dynamics is available online at www.generaldynamics.com.
For more information on American Petroleum Tankers, please visit www.americanpetroleumtankers.com.
Construction of the first tanker is scheduled to begin in the third quarter of 2014, with deliveries scheduled to begin in the fourth quarter of 2015, continuing through 2016. The four-ship APT contract will add up to approximately 800 jobs at NASSCO during construction and more than 165 seagoing union jobs during the operation of the vessels.
The 610-foot-long tankers are a new “ECO” design that offers improved fuel efficiency and incorporates the latest environmental protection features, including a Ballast Water Treatment System. All of the ECO-class tankers will be constructed at the NASSCO shipyard in San Diego. This contract builds upon the strong relationship NASSCO and APT developed during the construction of five State-class product carriers from 2007 to 2010.
The ships will be designed by DSEC, a subsidiary of Daewoo Shipbuilding & Marine Engineering (DSME) of Busan, South Korea. DSEC’s ECO design achieves improved fuel efficiency through several features, including a G-series MAN ME slow-speed main engine and an optimized hull form. The tankers will have dual-fuel-capable auxiliary engines and the ability to accommodate future installation of an LNG fuel-gas system. The ECO-class tankers represent the continuation of NASSCO’s successful partnership with DSEC, which was a partner on the five APT State-class product tankers and currently is contributing to two LNG-powered containerships for TOTE Shipholdings, Inc.
Fred Harris, President of General Dynamics NASSCO, said, “By continuing to bring the most economical and environmentally sound technology to Jones Act operators, these ECO tankers show our continued commitment to be one of the most innovative shipyards in America. I am pleased to renew our partnership with APT on this exciting new program. Along with TOTE, this is the second return customer we have welcomed back to NASSCO within the past six months, which speaks to the high-quality workmanship of our skilled workforce.”
The construction and operation of the new vessels are aligned with the Jones Act, which requires that ships carrying cargo between U.S. ports be built in U.S. shipyards.
Rob Kurz, CEO of APT, said, “This investment demonstrates our continued commitment to building and operating ships for the U.S. Jones Act trade. We are proud to bring new U.S.-built tonnage into the market at this exciting time, helping our country achieve its long-standing strategic objective of energy independence."
Sean Klimczak, Senior Managing Director of Blackstone, said, “This investment demonstrates our long-standing support of the U.S. maritime industry and our commitment to bolstering job creation in the U.S. We are pleased to partner again with NASSCO on this important newbuild program and to provide growth equity to APT to construct and bring these new, state-of-the-art vessels to market.”
For more information about General Dynamics NASSCO, please visit www.nassco.com. More information about General Dynamics is available online at www.generaldynamics.com.
For more information on American Petroleum Tankers, please visit www.americanpetroleumtankers.com.
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