Healthcare Industry News: WorldHeart
News Release - April 5, 2006
WorldHeart Expands RELIANT Trial Clinical Executive CommitteeTwo Leading Heart Failure Cardiologists Join Committee
Trial Enrollment Rate Increasing
OAKLAND, Calif., April 5 (HSMN NewsFeed) -- World Heart Corporation (Nasdaq: WHRT, TSX: WHT), a global technology leader in mechanical circulatory support systems, announced today that Dr. John B. O'Connell and Dr. Randall C. Starling have joined its Clinical Executive Committee for the Company's RELIANT trial (Randomized Evaluation of the Novacor® LVAS In A Non-Transplant Population).
Dr. O'Connell and Dr. Starling have joined Dr. Bartley P. Griffith of the University of Maryland Medical Center and Dr. James W. Long of LDS Hospital in Salt Lake City, Utah, on the Clinical Executive Committee. The members of this committee provide leadership and clinical direction for the RELIANT trial by working with clinical colleagues to share best practices, address clinical issues and expedite completion of the trial.
Dr. John B. O'Connell is the Director of the Center for Heart Failure, Bluhm Cardiovascular Institute and Professor of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. He has held numerous scientific leadership positions, including President of the International Society for Heart and Lung Transplantation and the Association of Professors of Medicine.
Dr. Randall C. Starling is Director of the Section of Heart Failure and Cardiac Transplant Medicine at Cleveland Clinic and Medical Director of the hospital's Kaufman Center for Heart Failure. He is a member of the Board of Directors of the International Society of Heart and Lung Transplantation, and serves on the Guidelines Committee of the Heart Failure Society of America. He has been a principal or co-principal investigator on numerous clinical trials, including National Institutes of Health grant-funded trials and has particular interest in devices and other forms of surgical therapy for heart failure and has published widely in this area.
Dr. O'Connell stated, "Mechanical circulatory support has advanced greatly over the past few years and the RELIANT trial will help incorporate Destination Therapy into conventional medical management. It is my goal to assist this important study to a successful completion."
Dr. Starling said, "I am pleased to be part of this important trial and the WorldHeart Clinical Executive Committee. The RELIANT trial is designed to evaluate options for patients with advanced heart failure who need mechanical circulatory support."
Jal S. Jassawalla, WorldHeart's President and Chief Executive Officer, said, "We are pleased to welcome Dr. O'Connell and Dr. Starling to the Clinical Executive Committee. Their history at the forefront of cardiac medicine will be an invaluable resource as WorldHeart moves to complete its RELIANT trial."
WorldHeart has already enrolled twelve patients in the trial to date this year, compared with nineteen enrollments in all of 2005, bringing the trial population to 36 patients enrolled since inception in 2004. WorldHeart expects the patient enrollment rate to increase as more of the 21 participating cardiac centers complete the required training processes and begin actively screening and enrolling suitable patient candidates.
About the RELIANT trial:
The RELIANT trial evaluates the Novacor LVAS for Destination Therapy use in patients suffering from irreversible left ventricular failure who are not candidates for heart transplantation. Recipients are randomized, on a 2:1 basis, to receive the Novacor LVAS or the HeartMate® XVE LVAS. The objective of the trial is to demonstrate that use of the Novacor LVAS is superior to optimal medical therapy by demonstrating equivalence to the HeartMate XVE LVAS, which has been evaluated and approved for such use. Data from this Trial is expected to support a Pre-market Approval Supplement that will request approval for use of the Novacor LVAS by non-transplant eligible patients (Destination Therapy).
About the Novacor® LVAS:
The Novacor LVAS is an electrically powered, pulsatile-flow device with more than 20 years of clinical use. It is the first ventricular assist device (VAD) to provide a recipient with more than 6 years of circulatory support and continues to hold the industry record for longest support on a single pulsatile device, over 4.5 years, statistics unmatched by any other implanted electromechanical circulatory support device on the market. To date, more than 1,700 patients have been supported with the Novacor, with close to 700 patient-years of experience, and no deaths attributable to device failure. The Novacor LVAS is commercially approved as a bridge to transplantation in the United States and Canada. In Europe, the Novacor LVAS has unrestricted approval for use as an alternative to transplantation, as a bridge to transplantation, and to support patients who may have an ability to recover the use of their natural heart. In Japan, the device is commercially approved for use in cardiac patients at risk of imminent death from non-reversible left ventricular failure for which there is no alternative except heart transplantation.
About World Heart Corporation
World Heart Corporation is a global technology leader in mechanical circulatory support systems dedicated to working with physicians to provide reliable, long-term use products and services to the broadest patient population through technology, leadership and innovation. The Company is headquartered in Oakland, California, USA with additional facilities in Salt Lake City, Utah and in Heesch, Netherlands. World Heart's registered office is Ottawa, Ontario, Canada.
Any forward-looking statements in this release, including planned preclinical and clinical studies and breadth of the company's product platform, are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including without limitation: risks in product development and market acceptance of and demand for the Company's products; possible delays in successfully completing current and planned clinical trials and preclinical testing; and other risks detailed in the Company's filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-KSB for year ended December 31, 2005.
Source: World Heart
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.