Cameron Health’s S-ICD® System Scheduled for FDA Panel Review on April 26, 2012
World’s Only Completely Subcutaneous Implantable Defibrillator is an Important New Alternative for Patients at Risk of Sudden Cardiac Arrest
SAN CLEMENTE, Calif. (March 19, 2012) – Cameron Health, Inc. (“Cameron Health”) announced today that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel will review the Premarket Approval (PMA) application of the S-ICD® System on April 26, 2012.
“The FDA advisory committee meeting represents a significant step towards obtaining U.S. approval of the S-ICD System,” said Kevin Hykes, Cameron Health’s President and CEO. “We look forward to the opportunity to discuss the safety and efficacy of the S-ICD System with the FDA review team. Our clinical data will demonstrate that the S-ICD System is a valuable new treatment option for patients at risk of sudden cardiac arrest.”
The FDA advisory panel will review clinical data on the safety and efficacy of the S-ICD System including the results of a Pivotal IDE Clinical Study of 330 patients at risk of SCA. The PMA application was submitted to the FDA in December, 2011.
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 is unique in that the implantation of the system is entirely subcutaneous, removing the need for lead placement inside the heart. Essentially, the S-ICD System eliminates the major clinical complications associated with transvenous leads. 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. Left unaddressed, these disorganized heart rhythms are often fatal.
About Sudden Cardiac Arrest (SCA)
SCA is a sudden, abrupt loss of heart function. Most SCA episodes are caused by the rapid and/or chaotic activity of the heart known as Ventricular Tachycardia or Ventricular Fibrillation. Recent estimates show that approximately 850,000 people in the U.S. are at risk of SCA and indicated for an ICD device, but remain unprotected. In fact, less than 35 percent of patients who are indicated for an ICD receive one. SCA is not the same as a heart attack. A heart attack is a malfunction caused by blockage in a vessel that supplies blood to the heart, which may permanently damage part of the heart. Unlike SCA, most people survive a first heart attack. SCA is an “electrical” malfunction of the heart that results in no blood flow to the body or the brain. SCA is fatal if left untreated. ICDs are proven to be 98 percent effective in treating dangerous heart rhythms that can lead to SCA.
About Cameron Health, Inc.
Cameron Health, Inc. (www.cameronhealth.com), headquartered in San Clemente, California, is a pioneer in the development, manufacture and distribution of the next generation of implantable defibrillators.
Cameron Health, Inc.