Cardiologist Warns on St. Jude Heart Device

The following is an excerpt from an article in

The New York Times
Wednesday, August 22, 2012

Cardiologist Warns on St. Jude Heart Device

By BARRY MEIER and KATIE THOMAS

A cardiologist who studies the safety of heart devices said surgeons should stop using a component sold by St. Jude Medical until more is known about the long-term safety of the device.

The cardiologist, Dr. Robert G. Hauser of Abbott Northwestern Hospital in Minneapolis, made his comments as a study he conducted was published online. His research suggests that a proprietary material used by St. Jude to coat wires that connect an implanted defibrillator to a patient’s heart is breaking down prematurely and, in some cases, leading to failure of the device. The study was published by EP Europace, a British cardiology journal.

St. Jude began using the coating, which is known as Optim, several years ago as a means of better protecting its leads from abrasion. But Dr. Hauser said a troubling number of cases had been reported to the Food and Drug Administration in which the Optim coating appeared to fail.

“There is no need to use this lead until we have more confidence in its performance,” he said in an interview Monday.

The company has vigorously defended the safety of Optim and its current defibrillator lead, which is known as the Durata and has been implanted in an estimated 278,000 patients worldwide, according to St. Jude.

In a statement Tuesday, the company noted that leads from all manufacturers can fail and said the Optim coating is 50 times more resistant to abrasion than silicone, the standard coating. St. Jude also said its product registries are monitoring 11,000 patients with the company’s current generation of leads, and it recently announced that it would follow patients in the registry with Optim-coated leads “indefinitely.”

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