Cameron Health’s S-ICD® System Meets Primary Safety and Efficacy Endpoints in IDE Clinical Study
IDE Study Results Presented in the Late-Breaking Session at Heart Rhythm 2012
S-ICD System is World’s First Completely Subcutaneous Implantable Defibrillator Eliminating Many of the Serious Complications Associated with Transvenous Leads
SAN CLEMENTE, Calif. – May 10, 2012 – Cameron Health, Inc. (“Cameron Health”) announced today that the S-ICD® System met the primary safety and efficacy endpoints defined in their 330 patient IDE clinical study. The data were presented at Heart Rhythm 2012, the Heart Rhythm Society’s 33rd Annual Scientific Sessions in Boston, MA by Martin C. Burke, D.O., from the University of Chicago as part of the Late-Breaking Scientific Session.
The S-ICD System is the world’s first completely subcutaneous (under the skin) implantable defibrillator (ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System offers the same defibrillation therapy option as most conventional ICDs, but without transvenous leads – thereby eliminating many of the serious complications commonly associated with transvenous leads.
"Conventional ICDs are a proven therapy with a long clinical track record; however, complications related to transvenous leads, or wires placed in the heart, can be quite serious for patients,” said Dr. Martin C. Burke, Professor of Medicine and Director of the Heart Rhythm Center at the University of Chicago. “We did not observe the typical lead-related complications with the S-ICD System, so having an alternative treatment for patients that can virtually eliminate transvenous lead complications is an important step forward for ICD therapy.”
The S-ICD System IDE trial is a prospective, non-randomized, multicenter clinical study that enrolled 330 patients meeting current AHA/ACC/HRS Class I and II ICD indications and who did not require long-term bradycardia pacing. The primary endpoints for the study were designed to demonstrate safety and efficacy of the S-ICD System for the treatment of life-threatening ventricular arrhythmias.
“The compelling results of this landmark clinical study add to the growing body of evidence that demonstrate the benefits of this important alternative for patients at risk from sudden cardiac arrest. Furthermore, we are equally committed to evaluating the real-world performance of the S-ICD System via our long-term EFFORTLESS S-ICD Registry,” said Kevin Hykes, President and CEO of Cameron Health. The preliminary results from the registry were also reported at the HRS.
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. In contrast to conventional ICDs, Cameron Health’s electrode is implanted 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. 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, where the heart suddenly stops pumping blood. It is almost always fatal if left untreated. When fatal, it is called sudden cardiac death (SCD). 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.