Healthcare Industry News: arrhythmia
News Release - March 18, 2010
Cameron Health Commences FDA-Approved IDE Clinical Trial of the Minimally Invasive Totally Subcutaneous Implantable Defibrillator for Treatment of Sudden Cardiac Arrest
SAN CLEMENTE, Calif.--(HSMN NewsFeed)--Cameron Health, Inc. today announced the commencement of the company's pivotal clinical trial to gain U.S. approval of its Subcutaneous Implantable Defibrillator (S-ICD®) System. The minimally invasive S-ICD System is prescribed for use in patients at risk of Sudden Cardiac Arrest (SCA). The S-ICD System is unique in that the implantation of the system is entirely subcutaneous; no leads are in or on the heart. Additionally, there is no imaging equipment required for placement of the S-ICD System, as all of the components are positioned using anatomical landmarks. The S-ICD System received CE approval in 2009 and is commercially available in Europe.Conventional ICD’s require placement of at least one lead in or on the heart. Most frequently, these leads, constructed of thin insulated wires, are threaded through a vein and then placed inside the heart. These conventional transvenous leads allow for sensing of the heart’s rhythm and delivery of a life saving electric shock when a harmful arrhythmia is detected. The surgical placement and long term implantation of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this highly effective therapy. In contrast, the Cameron Health S-ICD System resides just under the skin, potentially avoiding many of the complications associated with the conventional implant procedure.
Cameron Health’s trial is a prospective, multicenter, single-arm design approved by the FDA under an investigational device exemption (IDE). The company plans to enroll up to 330 subjects at up to 35 sites globally. The study has primary clinical endpoints of arrhythmia conversion efficacy and complication free rate at 6 months for patients at risk of SCA.
Jay Warren, President and CEO of Cameron Health, Inc. explains, “Our goals are to reduce or eliminate the risks that attend transvenous implants, to refine the state of the art in rhythm discrimination and to simplify implant, programming and follow up for the physician. In essence, our S-ICD System is designed to provide patients with a safe, efficacious and minimally invasive alternative to conventional ICD’s.”
The IDE trial will involve patients at centers in the U.S., Europe and New Zealand. The first IDE implants were performed in New Zealand by Dr. Margaret Hood at Auckland City Hospital and by Dr. Ian Crozier at Christchurch Hospital. Initial implants in the U.S. were performed by Dr. Martin Burke, Director of the Heart Rhythm Center at the University of Chicago.
Commenting on the first patient to receive the S-ICD System in the U.S., Dr. Burke said, “Given the simplicity of the implantation I can see the potential to reduce the surgical and long term complications inherent in transvenous ICD systems.” The first U.S. patient to receive Cameron Health’s S-ICD System was Brooke Bergeron, who at 38 years old, suffered a heart attack during the birth of her fourth child. Her doctors recommended an implantable defibrillator due to heart damage that put her at risk for SCA. Brooke remarked, “I chose this novel technology because I just like the idea of not having any leads in or on my heart.”
About The S-ICD® System
Components of the Cameron Health S-ICD System include the SQ-RX™ Pulse Generator, Q-TRAK™ Subcutaneous Electrode, Q-GUIDE™ Electrode Insertion Tool and the Q-TECH™ Programmer. The S-ICD System is implanted subcutaneously (just under the skin) with the electrode running parallel and slightly to the left of the sternum. While most functions are automatic, adjustments and data retrieval can be easily achieved through a highly advanced integrated programming system developed specifically for the S-ICD System. The Q-TECH programmer is one of the smallest units in the industry weighing less than three pounds. The light weight, portable unit is capable of wireless communication with the SQ-RX Pulse Generator.
About Sudden Cardiac Arrest
Sudden Cardiac Arrest (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.
Source: Cameron Health
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