Cameron Health Commences Clinical Trial Of The Minimally Invasive Totally Subcutaneous Implantable Defibrillator For Treatment Of SCA

Main Category: Cardiovascular / Cardiology
Also Included In: Vascular;  Clinical Trials / Drug Trials
Article Date: 08 Jan 2009 - 4:00 PDT

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Cameron Health, Inc. announces the first CE trial implants in Europe and New Zealand 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 ICDs 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. When approved, the S-ICD System will be the first totally subcutaneous implantable defibrillator used to treat SCA.

Jay Warren, President and CEO of Cameron Health, Inc., explains, "The technological advancements with the Cameron Health S-ICD System are designed to provide patients with a safe, minimally invasive alternative to conventional ICDs. Since the Cameron Health S-ICD System is placed by anatomical landmarks, there is no need for expensive imaging equipment."

Fourteen patients have received an S-ICD System as part of the CE trial, which will involve up to 55 patients at 10 centers in Europe and New Zealand. Implants performed in New Zealand were conducted by Dr. Margaret Hood at Auckland City Hospital and by Dr. Ian Crozier at Christchurch Hospital. Initial implants in Europe were under the direction of Dr. Riccardo Cappato at Policlinico San Donato Milanese Hospital in Italy and Professor Luc Jordaens at Erasmus Medical Center in the Netherlands.

Commenting on the clinical trial and the first CE trial patient to receive the S-ICD System in New Zealand, Dr. Hood said, "Our initial experience with this new technology has brought positive results. The whole procedure was surgically simple. Once implanted, the S-ICD System can be programmed to automatically optimize the device parameters for monitoring the heart's rhythm while removing some of the complexity inherent in conventional systems. Not having to wear a protective lead apron to avoid radiation exposure during the procedure was refreshing. All patients have returned to their normal routines and are doing well."

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. ICDs are proven to be 98 percent effective in treating dangerous heart rhythms that can lead to SCA.

About Cameron Health, Inc.

Cameron Health, Inc., headquartered in San Clemente, California, is a pioneer in the development, manufacture and distribution of the next generation of implantable defibrillators.

Cameron Health, Inc.