OAKLAND, CA, July 28 /PRNewswire-FirstCall/ - - World Heart Corporation (“WorldHeart” or the “Company”), a global technology leader in mechanical circulatory support systems, today announced a successful first animal implant of its Novacor II next-generation pulsatile pump.
The Novacor II, a next-generation pulsatile ventricular assist device (VAD), was implanted in a sheep as a test of its hemodynamic performance over a range of physiologic conditions. The Novacor II design is based on the proven technology of the Novacor(R) Left Ventricular Assist System (LVAS) currently in clinical use. Smaller and quieter than its predecessor, the new pump is driven by direct magnetic actuation, eliminating bearings and other components subject to wear.
“The implant represents a significant milestone in the development of this next-generation device”, commented Phillip Miller, WorldHeart’s Vice President of Research and Development, “and we are pleased to have reached it ahead of schedule. The Novacor II performed exactly as anticipated in this in vivo study, demonstrating its ability to provide circulatory support under true physiologic conditions. Upon completion of our acquisition of MedQuest Products, Inc. and their HeartQuest(TM) magnetically levitated centrifugal rotary VAD, WorldHeart will be, we believe, the only company with next-generation rotary and next-generation pulsatile pumps under development.”
The implant surgery was performed yesterday by Dr. Philip E. Oyer, Professor of Cardiothoracic Surgery, Stanford University School of Medicine. “The Novacor LVAS has long set the standard for reliability in this field”, noted Dr. Oyer, who performed the first clinical implant of the current Novacor LVAS. “This bearingless next-generation device, with its promise of even greater durability, is ideally suited to the widening use of VADs for Destination Therapy.”
Animal implants of the Novacor II will also be conducted at the Texas Heart Institute, under the direction of Dr. O. Howard Frazier, Chief of Cardiopulmonary Transplantation and Director of Cardiovascular Surgical Research. “As clinicians, we need both pulsatile and rotary pumps for our heart failure (HF) patients” said Dr. Frazier. “Rotary pumps function as true ‘assist’ devices for patients in late-stage heart failure, while pulsatile devices serve as true functional ‘replacements’ for the left heart in end-stage HF patients. We are pleased to be working with WorldHeart on the development of a unique next-generation pulsatile system.”
About Novacor(R) LVAS:
The Novacor LVAS, a pump implanted alongside the patient’s own heart to take over a large portion of the workload of the natural heart, supports end-stage heart failure patients. It is an electrically powered, pulsatile flow device with more than 20 years of clinical use. The Novacor LVAS has unprecedented reliability and durability. It is the first ventricular assist device to provide a recipient with more than 6 years of circulatory support and the first in the industry with record support on a single pulsatile device, 4.8 years. To date, more than 1,600 patients have been supported with the Novacor, with over 600 patient-years of experience and no deaths attributed to device failure.
The Novacor LVAS is commercially approved as a bridge to transplantation in the U.S. and Canada. In Europe, the Novacor LVAS has unrestricted approval for use as an alternative to transplantation, 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 medical device company headquartered in Oakland, California, USA with an additional facility in Heesch, Netherlands. WorldHeart’s registered office is Ottawa, Ontario, Canada.
Any forward-looking statements in this release 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, risks associated with costs and delays posed by government regulation, limitations on third-party reimbursement, inability to protect proprietary technology, potential product liability, delays in the completion of or an unsuccessful result in the RELIANT Trial and other risks detailed in the Company’s filings with the U.S. Securities and Exchange Commission, including its recently filed Proxy Statement and Amended Annual Report on Form 10-KSB/A for year ended 2004.
WORLD HEART CORPORATION
CONTACT: World Heart Corporation, Peggy Allman, (510) 563-4721,www.worldheart.com