FDA Advisory Panel Recommends Approval of Cameron Health's S-ICD® System for Patients at Risk of Sudden Cardiac Arrest
SAN CLEMENTE, Calif., April 26, 2012 — Cameron Health, Inc., working in the development, manufacture and distribution of next generation implantable cardioverter defibrillators (ICDs), announced today that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel voted 7-1 that sufficient data exists demonstrating the efficacy and safety of the S-ICD System for the treatment of sudden cardiac arrest (SCA).
"We are pleased with the panel's strong recommendation for approval of the S-ICD System, the world's first-and-only completely subcutaneous ICD for the treatment of sudden cardiac arrest," said Kevin Hykes, president and CEO of Cameron Health. "This represents another important step on the path toward FDA approval of the S-ICD System and, its availability to physicians and their patients at risk for sudden cardiac arrest."
Cameron Health submitted a Premarket Approval Application (PMA) in December 2011 based on data from a 330-patient Pivotal IDE Clinical Study which evaluated the safety and efficacy of the S-ICD System in patients at risk of SCA.
"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 Dr. Michael R. Gold, 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."
On March 8, 2012, Boston Scientific Corporation announced that it would exercise its option to acquire Cameron Health, Inc. Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.
About the S-ICD System
The S-ICD System was designed to provide the same proven defibrillation protection as conventional ICDs, but without the serious complications associated with leads that reside in the heart and blood vessels. The lead that monitors and, if needed, shocks the heart rests against the breastbone just under the skin. Implantation is straightforward, since the heart and blood vessels are untouched. The S-ICD System detects highly accelerated and disorganized heart rhythms caused by ventricular arrhythmias that can lead to sudden cardiac arrest. When abnormal arrhythmias are detected, the S-ICD System delivers an 80 Joule shock to restore the heart's normal rhythm.