Cameron Health initiates clinical trial of minimally invasive S-ICD System for patients at risk of SCA

Mar 19 2010

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.

“I chose this novel technology because I just like the idea of not having any leads in or on my heart.”

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.”