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

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US FDA advisers back Cameron Health heart device Apr 26th 2012, 20:44 WASHINGTON, April 26 | Thu Apr 26, 2012 4:44pm EDT 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 that the benefits of Cameron's device, which delivers electrical shocks to a dangerously irregular heartbeat to return it to a normal rhythm, outweighed its risks, according to the company and the FDA. They also voted 7-1 that the device worked and unanimously said it was safe. 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. The FDA usually follows panel recommendations, although it is not required to, and will make a final decision later. The defibrillator has been sold in major European countries since 2009. 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; 97.9 percent of people implanted with Cameron Health's device had no complications with their device after 180 days and the device also converted heart quivers to a normal rhythm in 98.9 percent of patients. Cameron Health said about 850,000 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. These devices treat the overly fast heart rhythms or quiver of heart muscles, which cause most cardiac arrests. Link this Share this Digg this Email Reprints

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