(RxWiki News) A U.S. Food and Drug Administration panel has voted 7-1 to back Cameron Health's new type of implantable heart defibrillator. It is the first defibrillator that does not require implanting an electrode near the heart.
Instead of using intracardiac leads, electrodes are implanted vertically under the skin on the chest. Implantable cardioverter defibrillators correct dangerous abnormal heart rhythms that could lead to sudden cardiac death.
The device will shock the heart if it detects problematic arrhythmias.
"Talk to a cardiologist about managing an arrhythmia."
Kevin Hykes, president and CEO of Cameron Health, said the company was pleased with the panel's strong recommendations for formal FDA approval of the S-ICD System, and said the vote represents an important step on the path toward FDA approval.
While the FDA's Circulatory System Devices Panel determined there was sufficient data to show efficacy and safety of the device for treating sudden cardiac death, it still must be formally approved by the FDA. In most cases the FDA approves devices recommended by its panels though it is not bound to do so.
Cameron Health, which is in the process of being acquired by Boston Scientific Corporation, originally submitted a Premarket Approval Application in December 2011. The request for approval was based on findings from the Pivotal IDE Clinical Study of 330 patients with arrhythmias at risk of sudden cardiac death. Researchers found that the S-ICD System was both safe and effective.
"The S-ICD System is a breakthrough technology that holds promise as a new alternative for treating patients at risk for sudden cardiac arrest," said Michael R. Gold, MD, PhD, professor of medicine and chief of cardiology at the Medical University of South Carolina.
"The S-ICD System provides the same defibrillation protection as conventional ICDs, but without the serious complications associated with leads that reside in the heart and blood vessels."
The device was approved in the European Union three years ago.