Tuesday, June 16, 2009

EU Issues OK for Minimally Invasive Subcutaneous Implantable Defibrillator

Filed under: Cardiac Surgery , Cardiology

Cameron Health out of San Clemente, California has seen its Subcutaneous Implantable Defibrillator (S-ICD®) System trialed in hospitals around the world, the results of which netted the company approval for the device across the European Union. Unlike traditional AICDs, Cameron's device does not require pacer-defibrillator leads to be placed in the heart, and therefore may overcome the various problems related to lead implantation and retention.

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 residence of these transvenous leads within the patient’s heart are associated with a significant proportion of the complications related to this well established and 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 and long term performance. The S-ICD System is also designed for ease of placement and removal while shortening the surgical procedure time. The S-ICD System is the first totally subcutaneous implantable defibrillator used to treat SCA. Market launch is scheduled to commence this summer in select geographies as Cameron Health ramps production.

Here's a link to the presentation given at this year's Heart Rhythm Society's Annual Scientific Session: Clinical Evaluation of the Subcutaneous Implantable Defibrillator (S-ICD®) System...

Press release: Cameron Health Announces CE Mark of the Minimally Invasive Totally Subcutaneous Implantable Defibrillator for Treatment of Sudden Cardiac Arrest...

Link: Cameron Health homepage...

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