Reuters: Regulatory News: UPDATE 1-US FDA advisers back Cameron Health heart device

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UPDATE 1-US FDA advisers back Cameron Health heart device Apr 26th 2012, 21:48 Thu Apr 26, 2012 5:48pm EDT * Device delivers shocks to irregularly beating heart * Boston Scientific in process of buying Cameron Health * Recent high-profile safety issues with defibrillators By Anna Yukhananov WASHINGTON, April 26 (Reuters) - U.S. drug advisers gave the nod to the first defibrillator designed to be implanted directly under the skin, raising hopes Cameron Health Inc's novel product would be approved. Outside advisers to the U.S. Food and Drug Administration voted 7-1 to recommend approval of Cameron's device, which delivers electrical shocks to a dangerously irregular heartbeat to return it to a normal rhythm. They also voted 7-1 that the device worked and unanimously said it was safe, according to the company and the FDA. The product gained renewed attention after Boston Scientific Corp, one of the top three makers of heart devices, agreed in March to buy privately held Cameron Health for $150 million and add another $150 million if the defibrillator gained FDA approval. Shares of Boston Scientific closed up 0.5 percent at $6.18. The FDA usually follows panel recommendations, although it is not required to, and will make a final decision later. The defibrillator has been available in major European countries since 2009, with about 1,200 devices sold, the company said. Earlier this week, reviewers from the FDA said Cameron's defibrillator might cause more infections and work less quickly than similar devices implanted in the heart. But the FDA staff also said the company met safety and effectiveness goals during clinical trials. Cameron Health said about 800,000 people in the United States are at risk of sudden cardiac arrest, when the heart suddenly stops beating, making them eligible for an implantable defibrillator. Like similar devices, Cameron Health's defibrillator, called the S-ICD, delivers electric shocks to help a fluttering heart beat normally. But its electrodes are threaded under the skin along the breastbone, rather than directly into the heart. In-heart electrodes are known as transvenous leads. Cameron Health has said its device is easier to implant than transvenous leads because it does not require an X-ray machine, and may be safer because it is easier to remove than devices inside the heart in the event of a problem. Boston Scientific, Medtronic Inc and St. Jude Medical Inc all make implantable defibrillators. During discussions on Thursday, panelists and FDA reviewers focused on "inappropriate" shocks from the device, when 30.7 percent of patients in clinical trials received an electric shock to the heart without having an overly fast heart rhythm or quiver of the heart muscles. However, about a third of shocks with transvenous leads are also inappropriate, the FDA said. The leads are the wires that carry electricity to the heart. Safety issues with defibrillator leads made headlines recently, after St. Jude Medical was forced to halt sales of two of its leads due to concerns the insulation could wear away and expose the wires. Kevin Hykes, Cameron Health's chief executive, said the company was confident doctors would be able to use its device safely, and is hoping to get a final response from the FDA by the end of the year. "Despite some controversy lately, defibrillation therapy is a life-saving therapy that has changed some lives," he said in an interview. "(Today) is a big day for Cameron Health, and an even bigger day for patients." Link this Share this Digg this Email Reprints

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