FDA panel recommends Boston Scientific’s electronic heart device for less-severe heart disease

Thursday, March 18, 2010

FDA panel backs implant for mild heart failure

COLLEGE PARK, Md. — Federal health advisers said Thursday an electronic heart implant should be approved for a large group of heart-disease patients who currently aren’t eligible for the device.

A Food and Drug Administration panel of cardiologists voted unanimously in favor of Boston Scientific’s heart-regulating device to treat mild heart failure, so long as the company tracks the long-term safety of patients.

The FDA is not required to follow the panel’s advice, though it often does. Currently the device is approved for moderate to severe heart failure.

A positive FDA decision would expand the market for the devices by tens of thousands of patients.

The device combines a defibrillator, which shocks the heart to correct irregular beats, with a resynchronization device to coordinate the pumping action of the heart. Currently most heart failure patients receive a defibrillator alone.

The two-in-one combination device is known as a cardiac resynchronization therapy defibrillator.

Boston Scientific Corp.’s presentation showed that patients implanted with a resynchronization defibrillator were 34 percent less likely to be hospitalized or experience other heart-related events when compared patients who only received a defibrillator. While there was no difference in death rate between the groups, panelists said the reduction in hospitalizations was enough to warrant approval.

“I think it’s a laudable and highly usable endpoint that alone justifies the approval,” said Dr. John Somberg of Rush University Medical Center.

Panelists discussed the fact that patients with a synchronization device experienced more adverse side effects than those with defibrillators. About 15 percent of patients with the combination device had complications, compared with 7.6 percent of defibrillator patients.

Considering those side effects and the lack of impact on lifespans, panelists unanimously said the company should be required to track patients long-term to confirm the device’s benefits.

“We need more evidence of whether it’s worth it to have some of these upfront complications in order to avoid more hospitalizations years down the road,” said panel member Dr. Michael Domanski, of the National Institutes of Health.

FDA is scheduled to make a final decision by mid-June.

Even with FDA approval, there could be stumbling blocks for widespread use of the device. Resynchronizers cost between $30,000 to $40,000, not including the cost of implantation. And patients with mild heart failure, who are not experiencing painful symptoms, might be reluctant to have surgery to get the device.

Sales growth of heart-pacing devices has been flat in recent years due to market saturation and safety concerns involving recalled devices. Boston Scientific Corp. and competitors Medtronic Inc. and St. Jude Medical Inc. are targeting patients with mild heart failure as the potential future market for their devices.

In the U.S., about 60,000 patients with severe heart disease get the devices every year, out of 5.5 million people who have heart failure. More than 3.8 million of those patients have mild to moderate heart failure.

Boston Scientific, which is based in Natick, Mass., does not separate sales of defibrillators and resynchronization implants, but the devices combined accounted for 15 percent of company revenue.

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