SAN CLEMENTE, Calif.--()--Cameron Health, Inc. (“Cameron Health”) announced today that the 1,000th patient was recently implanted with the S-ICD® System, the world’s only completely subcutaneous implantable defibrillator.
The 1,000th patient was implanted by Lara Dabiri Abkenari, M.D., in association with Professor Luc Jordaens, M.D., Ph.D., at the Erasmus Medical Center in Rotterdam, the Netherlands. Professor Jordaens remarked, “We have gained significant insight into this new technology over the past two years and are encouraged by the results. The avoidance of transvenous lead placement has significant implications for both short and long-term complication rates.”
"Our experience with these first 1,000 patients has confirmed that the S-ICD System is a valuable new treatment option for both primary and secondary prevention patients at risk of sudden cardiac arrest. In addition, the S-ICD System provides an important alternative for patients that are not candidates for conventional transvenous ICD systems,” said Kevin Hykes, Cameron Health’s President and CEO.
“The S-ICD System has the inherent advantage of not requiring an electrode inside of the heart,” said Reinoud Knops M.D., at the Amsterdam Medical Center, the Netherlands. “It will be important to investigate how the less-invasive approach of the S-ICD System will impact the rate of serious complications in comparison to traditional transvenous ICD systems.”
In order to evaluate the performance of the S-ICD System in the real-world setting, Cameron Health recently initiated the EFFORTLESS™ Registry in Europe and New Zealand. EFFORTLESS will follow the S-ICD System in 1,000 patients for a period of 60 months post implant.
In the US, Cameron Health plans to submit clinical data from its recently completed, 330-patient S-ICD System Pivotal IDE Clinical Study to the FDA in early 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 risks 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. 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.