OAKLAND, Calif., March 30 /PRNewswire-FirstCall/ -- World Heart Corporation , a global technology leader in mechanical circulatory support systems, today announced that its next-generation pulsatile left ventricular assist system (“LVAS”), the Novacor II, has entered a key phase of animal testing on the development pathway toward human trials. The successful animal implant took place yesterday at the University of Utah in Salt Lake City, Utah, and was performed by a team headed by Dr. James Long, Director of the Utah Artificial Heart Program at LDS Hospital in Salt Lake City. “The combination of durability and smaller size of the Novacor II LVAS is expected to result in less traumatic surgery, faster recovery, and higher quality of life for patients,” said Dr. Long.
The Novacor II LVAS is the only small, bearingless next-generation pulsatile ventricular assist device in development. Built on proven Novacor LVAS(R) technology, the blood pump is driven by direct magnetic actuation, eliminating any components subject to wear and promising enhanced long-term durability. WorldHeart believes that there is a clinical need for both pulsatile and rotary devices for advanced heart failure (HF) patients, with pulsatile devices suited to providing full support or “functional” replacement for the left heart in end-stage HF patients and rotary devices providing partial support or “assist” in late-stage HF patients.
“We plan to conduct a series of animal implants in this pre-clinical stage over approximately the next 15 months,” said Jal Jassawalla, WorldHeart President and CEO. “We are pleased to enter this advanced phase of development. We look forward to feedback from the surgeons to help us continue to refine this next-generation product before we begin the clinical trials expected to take place in late 2007.”
The Novacor II has previously undergone animal implantation to assess hemodynamic performance under acute conditions. The current series of tests is required to validate the biocompatibility of the system during long-term or chronic use. Ultimately, the device is expected to enter clinical trials for Destination Therapy use, supporting the circulation of end-stage HF patients. Destination Therapy is called for when patients have irreversible heart failure, and are not candidates for heart transplantation.
WorldHeart’s current Novacor LVAS is an electrically powered, pulsatile flow device implanted alongside the patient’s own heart to take over a large portion of the workload of the natural heart, supporting end-stage HF patients. Approved for human use in the U.S., Canada, Europe and Japan, it has demonstrated high reliability and durability over 20 years of clinical application. WorldHeart is the only medical device company with both next generation pulsatile and rotary pumps in development. Its rotary pump, the only bearingless, centrifugal, magnetically levitated pump in development, entered clinical trials this month, with a successful first human implant in Thessaloniki, Greece.
Heart failure affects nearly five million Americans of all ages and is responsible for more hospitalizations than all forms of cancer combined. The Heart Failure Society of America, the American College of Cardiology and the American Heart Association have all recommended ventricular assist devices for permanent mechanical circulatory support in patients with severe heart failure who are not candidates for heart transplantation.
About World Heart Corporation
World Heart Corporation is a global technology leader in mechanical circulatory support systems 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.
WorldHeart is dedicated to working with physicians to provide reliable, long-term mechanical circulatory support products and services to the broadest patient population through technology, leadership and innovation.
Any forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements and expectations regarding the Company’s clinical development plans for Novacor II LVAS as well as its rotary pump and other statements that can be identified by the use of forward-looking language, such as “believes,” “feels,” “expects,” “may,” “will,” “should,” “seeks,” “plans,” “anticipates,” or “intends” or the negative of those terms, or by discussions of strategy or intentions. 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 Novacor LVAS product; costs and delays associated with clinical trials; limitations on third-party reimbursement; inability to protect proprietary technology; inability to achieve continued synergies associated with the MedQuest acquisition; slower destination therapy adoption rate for VADs including the Novacor LVAS; need for additional financing and other risks detailed in the Company’s filings with the United States Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the 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 Jordan Goldstein,+1-415-439-4520 or Matt Dallas, +1-212-850-5627, both of FinancialDynamics, for World Heart Corporation
Web site: http://www.worldheart.com/
