Cameron Health Announces CE Mark Of The Minimally Invasive Totally Subcutaneous Implantable Defibrillator For Treatment Of Sudden Cardiac Arrest

Main Category: Cardiovascular / Cardiology
Also Included In: Heart Disease;  Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 17 Jun 2009 - 0:00 PDT

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Cameron Health, Inc. announces CE approval for Cameron Health's 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 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 may be positioned using anatomical landmarks.

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.

Jay Warren, President and CEO of Cameron Health, Inc. explains, "our goal was to develop a minimally invasive alternative to conventional ICD's as well as tackle a number of the unmet needs of patients and physicians. We have made a number of significant advances, the foremost being that the Cameron Health S-ICD System obviates the need for transvenous lead placement."

Commenting on the S-ICD System, Dr. Ian Crozier from ChristChurch in New Zealand said, "This new approach to ICD therapy is better for a significant portion of my ICD patients. The procedure is surgically simple and may reduce or eliminate some of the complexity inherent with transvenous electrodes. For the implanting clinician, not having to wear a protective lead apron to avoid radiation exposure during the procedure was refreshing."

Darryl Ward, one of the first patients to receive the Cameron Health S-ICD System remarked, "I feel fortunate that this novel technology was available to me because my previous conventional ICD lead was no longer functioning. I just like the idea of nothing needing to be inside my heart anymore."

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 95 percent fatal if left untreated. ICD's are proven to be 98 percent effective in treating dangerous heart rhythms that can lead to SCA.

Source
Cameron Health, Inc.