OAKLAND, Calif., Jan. 5 /PRNewswire-FirstCall/ -- World Heart Corporation , a global technology leader in mechanical circulatory support systems, today provided an update of its current and planned clinical trial programs, highlighted by expanded new center enrollment in its RELIANT trial and the upcoming feasibility trial of its next-generation rotary VAD.
RELIANT TRIAL
WorldHeart continues to make progress in the expansion of its RELIANT trial (Randomized Evaluation of the Novacor(R) LVAS In A Non-Transplant Population). There is significant clinician interest in the trial, and in the use of the Novacor LVAS in an application that takes full advantage of its long-term reliability and multiyear durability. Twenty clinical centers are now enrolled in the RELIANT trial and several additional centers are in process. To date, twenty-four patients have been recruited at eleven centers. There have been no trial delays, and patient recruitment continues. Patient recruitment is expected to accelerate as additional centers complete the lengthy (six to nine month) administrative and training process and become active, and a critical mass of twenty active centers is reached. The company is also pursuing options to broaden the currently restrictive study inclusion criteria, which is expected provide a further increase in patient recruitment rate.
WorldHeart Rotary VAD Trial
Progress toward clinical evaluation of WorldHeart’s rotary VAD continues on track. WorldHeart was recently notified by the Ethics Committee of St. Luke’s Hospital in Thessaloniki, Greece of approval to proceed with the clinical feasibility study of its rotary VAD. The clinical evaluation is expected to begin in early 2006, pending completion of preclinical testing and acceptance of the clinical investigation application by the Greek ministry of health. We believe that this will be the first use in humans of a bearingless, fully magnetically levitated, centrifugal VAD.
The WorldHeart rotary VAD is an advanced, next-generation, continuous flow pump. Full magnetic levitation of its impellor eliminates wear mechanisms within the pump, and is expected to provide improved blood compatibility by allowing greater clearances and more favorable blood flow around the impeller.
In commenting on recent trial progress and the company’s product platform, Jal S. Jassawalla, WorldHeart’s President and Chief Executive Officer said, “We are pleased with the interest and progress made in our RELIANT trial and in the pre-clinical development of our advanced rotary system. Together with our next-generation pulsatile Novacor II system, we believe we will have the broadest platform of next-generation ‘assist’ and ‘replacement’ systems under development to meet the needs of late and end-stage heart failure patients. We look forward, in 2006, to accelerating RELIANT enrollment, the clinical trial of our rotary system and chronic animal trials of the Novacor II.”
Other Recent Milestones -- Four new clinical centers were added in the fourth quarter of 2005, increasing the customer base by eight new centers over the past year. -- Data from the INTrEPID feasibility study (Investigation of Non-Transplant Eligible Patients who are Inotrope Dependent) was presented at the 2005 Scientific Sessions of the American Heart Association meeting in Dallas by Duke University cardiologist Joseph Rogers, M.D. The study found that patients who received a Novacor LVAS for Destination Therapy had an average survival time more than three times longer than control patients who received optimal medical therapy but no device. The LVAS patients also scored significantly higher on standard measures of quality of life than patients in the control group. Study patients in the device arm were supported for as long as four years or more, on their original devices. -- A successful first animal implant of our next-generation pulsatile Novacor II LVAS by Dr. Philip E. Oyer, Professor of Cardiothoracic Surgery at Stanford University School of Medicine. The Novacor II LVAS is a small, bearingless next-generation pulsatile VAD building on proven Novacor LVAS technology. The blood pump is driven by direct magnetic actuation, eliminating any components subject to wear and promising enhanced long-term durability. About World Heart Corporation
World Heart Corporation is a global medical device company 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, the acceleration of clinical trial enrollment rates, broadening of trial inclusion criteria, 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 Amended Annual Report on Form 10-KSB/A for the year ended December 31, 2004.
World Heart Corporation
CONTACT: Mr. Richard Juelis, +1-510-563-4713, or Ms. Peggy Allman,+1-510-563-4721, both of World Heart Corporation
Web site: http://www.worldheart.com//
