Cameron Health Announces Launch of EFFORTLESS S-ICD Registry to Capture Long-Term Outcomes of S-ICD® System Designed to Treat Sudden Cardiac Arrest

Study to Follow 1,000 Patients Implanted with Defibrillator for Five Years

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--Cameron Health Inc. (www.cameronhealth.com) today announced the first patient enrollment in the company's landmark EFFORTLESS S-ICD^® System Registry by Dr Marcoen Scholten, Medisch Spectrum Twente, Enschede, The Netherlands. The S-ICD System (Subcutaneous-Implantable Cardioverter Defibrillator) is designed to provide life sustaining therapy to patients at risk of Sudden Cardiac Arrest (SCA). The device received CE mark in Europe in 2009 and has been implanted in over 500 patients worldwide. In the United States, the S-ICD is being studied in a 45-center FDA clinical trial.

“The EFFORTLESS S-ICD Registry is designed to rigorously collect long-term clinical outcome data, which demonstrates the commitment of Cameron Health to understanding and characterizing the performance of the S-ICD in the real world environment.”

The EFFORTLESS S-ICD Registry (Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness of the S-ICD System) is an international, multicenter Registry being led by Dr Pier Lambiase of The Heart Hospital, London and is designed to document and measure early, mid- and long-term clinical and cost-effectiveness outcomes associated with the implantation of the S-ICD System. The Registry will enroll patients who were implanted with the technology since its commercial release in 2009. Data will be collected from approximately 1,000 patients for up to five years from the date of their device implant.

“The S-ICD System represents a potentially groundbreaking advance in ICD technology and there is significant interest within the medical community regarding its long-term efficacy,” said Dr Scholten. “The EFFORTLESS S-ICD Registry is designed to rigorously collect long-term clinical outcome data, which demonstrates the commitment of Cameron Health to understanding and characterizing the performance of the S-ICD in the real world environment.”

The S-ICD System is unique in that the implantation of the system is entirely under the skin but outside the ribcage, eliminating the need for wires (leads) to be placed within or on the heart. It detects very fast any disorganized heart rhythms and provides a jolt of electricity (or shock) to restore the heart’s normal rhythm and prevent SCA. Left unaddressed, these disorganized heart rhythms are fatal approximately 95% of the time.

Conventional implantable defibrillators, or ICDs, require at least one wire to be routed through the vascular system which is then directed to the desired placement within or on the heart. While the therapy these conventional transvenous systems offer is lifesaving, occasionally, the wires have to be extracted or replaced. Extraction of a transvenous lead from the heart is complex and not without significant risk.

“ICD therapy is one of today’s most effective medical technologies, but it can also be associated with a number of significant complications,” explains Kevin Hykes, President and CEO of Cameron Health, Inc. “The S-ICD is designed to reduce complications and simplify ICD therapy, allowing more patients to be protected from SCA. The EFFORTLESS Registry is an important strategic initiative that will help to quantify the long term benefits of the S-ICD, and further demonstrates the company’s commitment to rigorous science.”

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.

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