The FDA’s Circulatory System Devices panel voted 7-1 on Thursday that the benefits of the Cameron Health subcutaneous ICD system (S-ICD) outweigh the risks in appropriately selected patients.
Unlike all previous ICDs, the S-ICD is much easier to implant because it is does not require threading a lead to connect the device to the heart. Panel member Rick Lange said the S-ICD was an example of “I-should-have-thought-of-that technology”, according to Heartwire reporter Reed Miller on twitter. That sentiment was echoed by device giant Boston Scientific in March when it agreed to acquire Cameron Health for $150 million initially, and as much as $1.2 billion in additional payments based on future performance, according to Reuters.
The advisory panel also voted 7-1 that the S-ICD was effective and 8-0 that it was safe.
Earlier this week, FDA reviewers posted the previously unavailable results of the pivotal trial for the S-ICD. The FDA review set the tone for a generally supportive panel meeting, finding that the trial met its primary safety and efficacy endpoints, though it identified several potential safety issues.
Here is the press release from Cameron Health:
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 /PRNewswire/ – Cameron Health, Inc. (“Cameron Health”), a pioneer 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. 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.|
SOURCE Cameron Health, Inc.