SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Cameron Health, Inc. announced today that it has completed enrollment in its pivotal FDA clinical study of the S-ICD System, the world’s only completely subcutaneous implantable defibrillator.
The S-ICD System pivotal study is a prospective multicenter, single-arm study design approved by the FDA under an investigational device exemption (IDE). Clinical investigators enrolled 330 patients at risk for sudden cardiac arrest (SCA) at 33 centers in the United States, Europe and New Zealand. The pivotal study has primary clinical endpoints of arrhythmia conversion efficacy and complication-free rate at six months for qualified patients. The top 5 enrolling centers in the S-ICD System pivotal study were The Ohio State University, University of Chicago, Emory University, Sentara Heart Hospital and Auckland City Hospital.
"Completing enrollment in the S-ICD System pivotal study is another key milestone for the S-ICD System, and for Cameron Health. The data from this pivotal study will support our US approval process, which will ultimately significantly expand access to this important new technology for patients at risk of SCA,” said Kevin Hykes, President and CEO, Cameron Health.
Cameron Health plans to submit data from this pivotal study to the FDA in late 2011 requesting marketing approval for the S-ICD System in the United States. The S-ICD System received CE mark in Europe in 2009 based on data recently published in the July 2010 issue of the New England Journal of Medicine. Approximately 800 patients have been implanted with the S-ICD System worldwide.
"The S-ICD System is an important new technology that will be a viable treatment option for patients at risk for SCA,” said Dr. Raul Weiss, Associate Professor-Clinical, Cardiovascular Medicine at The Ohio State University. “The S-ICD System represents the first meaningful advance in ICD technology in many years.”
The S-ICD System is unique in that the implantation of the system is entirely subcutaneous, eliminating the need for electrical wires (leads) to be placed in the heart. The S-ICD System detects highly accelerated and disorganized heart rhythms and provides a jolt of electricity (or shock) to restore the heart’s normal rhythm and prevent SCA. Left unaddressed, these disorganized heart rhythms are often fatal.
"We are encouraged by our experience with the S-ICD System in this pivotal study and look forward to reporting the results. Having the option to implant an ICD that does not require placement of leads directly in the heart would be an important new alternative for countless patients. The S-ICD System represents a true breakthrough backed by years of research,” said Dr. Martin Burke, Director of the Heart Rhythm Center at the University of Chicago.
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. ICD’s 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.