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A federal advisory panel backed a new type of implantable heart defibrillator being developed by Cameron Health Inc., saying it represents an additional treatment option for people who are at risk of sudden cardiac arrest from an abnormal heartbeat.
Boston Scientific Corp. (BSX) is in the process of buying Cameron, based in San Clemente, Calif., as part of a deal that is expected to close later this year.
An implantable defibrillator is a device that delivers electric shocks to a patient's heart whenever a life-threatening cardiac rhythm is detected in order to correct the heartbeat. Current implantable defibrillators require thin, insulated wires to pass through blood vessels and into the heart, while Cameron's system sits underneath the skin and doesn't touch the heart.
"Defibrillator therapy has saved millions of lives," said Kevin Hykes, Cameron Health's chief executive. "We believe we have a solution to the Achilles' heel of this therapy" by eliminating the placement of lead wires in or on the heart.
Cameron's device was reviewed Thursday by the Food and Drug Administration's Circulatory System Devices Panel, which is made up of non-FDA medical experts.
The panel unanimously said the device was effective and voted, 7-1, on a question that asked if the product was safe. The panel also voted, 7-1, in favor of a question that asked if the benefits of the device outweighed the risks, which amounts to a recommendation that the agency approve the product.
Quick approval of the device isn't guaranteed, however. The agency said it wouldn't approve it until concerns about the device's battery life are completely addressed. The FDA also said it was concerned about infections and the number of "inappropriate" shocks delivered to the heart, which can hurt patients and drain the product's battery prematurely.
The agency did say that the elimination of a lead wire into the heart was the product's "primary benefit."
The leads in conventional defibrillators are susceptible to damage because the heart's regular pounding can stress a lead over time and, in rare instances, cause it to fail. The problem got fresh attention last month when the cardiac-medical journal Heart Rhythm reported that St. Jude Medical Inc.'s (STJ) Riata and Riata ST heart wires, which are still implanted in 79,000 U.S. patients, had been linked to 20 deaths. The company stopped selling the Riata devices in December 2010.
St. Jude has said it believes Riata and Riata ST's performance is comparable to that of other defibrillator leads that were on the market in the past decade. In 2007, Medtronic Inc. (MDT) pulled from the market a brand of wire that sometimes fractured and has been linked to at least 13 deaths out of more than 200,000 implanted.
The FDA said a clinical study looking at Cameron Health's defibrillator, which enrolled 330 patients, exceeded agency effectiveness and safety goals. But the agency said the safety goal didn't include all device complications such as 18 infections, four of which required the device to be removed.
The agency also said about 31% of shocks delivered by the device were considered inappropriate, meaning the system delivered a shock when it wasn't supposed to. But, FDA and doctors on the advisory panel said that rate was similar to that seen with traditional defibrillators.
Representatives for Cameron Health said the inappropriate shock rate has since been reduced with programming changes to the device, along with the infection rate. The product is approved for use in Europe.
Last year, Cameron Health discovered a problem with the batteries in some of devices after a battery was depleted less than six months after the device was implanted. The battery and device are meant to last for at least five years. The FDA said there's been three additional reports of premature battery depletion.
"FDA will not consider...approval of the device until this issue is resolved," the agency said. However, FDA said it expects the issue to be resolved, and the company said, in a document prepared for the meeting, that the battery depletion issue has been addressed.
-By Jennifer Corbett Dooren, Dow Jones Newswires, 202-862-9294; firstname.lastname@example.org
--Thomas M. Burton contributed to this article.