OAKLAND, Calif., April 10 /PRNewswire-FirstCall/ -- World Heart Corporation , a global technology leader in mechanical circulatory support systems, announced today that several clinical papers involving the Novacor(R) LVAS were presented at the 26th Annual Conference of the International Society for Heart and Lung Transplantation (ISHLT) held last week in Madrid, Spain.
Dr. Aly El-Banayosy from the Heart and Diabetes Center in Bad Oeynhausen, Germany, presented the institution’s extensive experience with patients discharged to their homes while supported by various ventricular assist devices (VADs). The Heart and Diabetes Center is the world’s busiest VAD center, and has implanted more than 130 of WorldHeart’s Novacor heart pumps. The center evaluated patient quality of life utilizing an independent, expert group blinded to the type of device used. Dr. El-Banayosy said, “Today’s VAD recipients spend most of their time in their own environment at home and at work. We assessed Quality-of-Life Scores from patients on various pulsatile and continuous flow devices and found that patients with the Novacor LVAS had the most favorable scores. The Novacor’s unmatched reliability and its ability to adjust automatically to changes in physiological conditions are well appreciated by our patients.”
Dr. Piet Jansen, WorldHeart’s Chief Medical Officer, said, “In Europe, where there is no restricted indication for VAD implantation, the Novacor LVAS has been used for periods exceeding 6 years. It is during those long-term support durations that device reliability and autoregulation are key to quality of life.”
WorldHeart Meeting in Madrid
On Friday, April 7th, WorldHeart hosted a meeting attended by 50 clinicians from eight countries. The participants were updated on the Company’s RELIANT trial (Randomized Evaluation of the Novacor LVAS In A Non-Transplant Population) progress, the initial clinical implant of the WorldHeart Rotary VAD and the start of chronic animal testing with the Novacor II next-generation pulsatile pump.
The RELIANT trial has seen an increase in enrollment rate. Twelve patients have been enrolled to date this year, the same number as in the entire second half of 2005. Thirty days have passed since the first human implant of WorldHeart’s magnetically levitated Rotary VAD took place in Thessaloniki, Greece. The recipient is recovering steadily and doing well. Chronic animal implants were recently initiated with the Novacor II LVAS, a small, bearingless, next-generation pulsatile ventricular assist device driven by direct magnetic actuation. The tests are required to validate the biocompatibility of the system during long-term or chronic use.
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. 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(R) 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 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.
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. WorldHeart’s registered office is Ottawa, Ontario, Canada.
Any forward-looking statements in this release, including those regarding 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.
World Heart Corporation
CONTACT: Mr. Richard Juelis, +1-510-563-4713, or Ms. Peggy Allman,+1-510-563-4721, both of World Heart Corporation; or Matt Dallas,+1-212-850-5627, or Jordan Goldstein, +1-415-439-4520, both of FinancialDynamics, for World Heart Corporation
Web site: http://www.worldheart.com/
