Sunshine Heart Announces IDE Approval To Begin C-Pulse U.S. Clinical Feasibility Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 13 Sep 2008 - 0:00 PDT

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Sunshine Heart (ASX: SHC), a global medical device company focused on innovative heart assist technologies, announced that it has received conditional approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its first U.S. clinical feasibility trial for the C-Pulse(TM) device in patients with moderate heart failure. C-Pulse is an implantable aortic cuff, designed as a cost effective heart assist therapy. The device is a uniquely positioned Class III heart failure therapy that offers an innovative intervention bridging the clinical gap between heart failure pacemakers and end stage therapies which potentially creates a new market opportunity.

Enrollment is expected to begin at six premiere U.S. medical institutions by the end of 2008. The objective of the trial is to evaluate the safety and efficacy of C-Pulse in 20 patients currently suffering from moderate heart failure. William Abraham, MD, of Ohio State University, and Patrick McCarthy, MD, of Northwestern University Medical Center, will serve as national co-lead principal investigators. Each patient's performance with C-Pulse will be closely monitored over a six month follow-up period.

Following the trial's successful completion, the Company will request CE Mark approval to market C-Pulse in the E.U. and other international countries that honor CE Mark label claims for device safety. In addition, the Company will seek FDA approval for a larger randomized U.S. pivotal study to support the submission of a marketing application for C-Pulse in the U.S.

Malcolm McComas, Chairman of the Board commented, "We are proud to announce that Sunshine Heart is the first company to receive FDA approval to run a clinical trial evaluating a non-blood contacting heart assist device. The agency's clinical approval of this treatment approach for moderate heart failure raises Sunshine Heart's profile as a global development stage medical device company supported by internationally renowned trial centers and lead investigators."

Donald Rohrbaugh, Chief Executive Officer, said, "We are very encouraged by the FDA's IDE approval for C-Pulse and look forward to generating additional data from this study to support our global regulatory strategy. Our C-Pulse heart assist therapy offers a unique treatment to patients who are suffering from moderate heart failure and represents an important advancement in addressing this significant unmet clinical need. If left untreated, moderate heart failure is a debilitating disease that can lead to premature death. We believe that C-Pulse represents one of the most innovative therapies in development for this indication in patients who no longer receive symptom relief from medication or cardiac synchronization pacemakers. With more than five million people suffering from heart failure today and a half million more diagnosed each year, we are extremely confident in the advantages C-Pulse provides to patients as a simple, safe, less invasive, non-blood contacting implant option."

About Sunshine Heart

Sunshine Heart (ASX: SHC) (http://www.sunshineheart.com) is a global medical device company, committed to the commercialization of C-Pulse(TM) an implantable, non-blood contacting, heart assist therapy for the treatment of people with heart failure. Through the use of counterpulsation technology, C-Pulse(TM) is designed to increase cardiac output while reducing the heart's workload for ventricular loading. Sunshine Heart listed on the ASX in September 2004 has a presence in Australia, New Zealand and the United States of America.

Forward Looking Statements

This press release contains forward-looking statements that are based on current management expectations. These statements may differ materially from actual future events or results due to certain risks and uncertainties from time to time in the Company's filings with the Australian Securities Exchange.

Sunshine Heart
http://www.sunshineheart.com