OAKLAND, Calif., Dec. 14 /PRNewswire-FirstCall/ -- World Heart Corporation ("WorldHeart") , a developer of mechanical circulatory support systems, announced today that two Canadian clinical teams have successfully completed technical and clinical training for use of WorldHeart's Levacor rotary ventricular assist device (VAD). The announcement follows the November 14, 2006 press release that the Company has embarked on a major restructuring of its business, which will enable it to better focus its operations on the development of its next-generation rotary VAD.
Cardiac surgeons, cardiologists and operating room staff from Toronto General Hospital and the University of Ottawa Heart Institute participated in the training, which was conducted at WorldHeart's Salt Lake City facility and the University of Utah in Salt Lake City, Utah. The training was organized to prepare both teams for clinical use of WorldHeart's rotary VAD as a bridge to cardiac transplant under Health Canada's Therapeutic Product Directorate Special Access Program, pending final internal approvals at both institutions.
Product shipment to both Canadian institutions and in-service training have been completed.
Dr. Vivek Rao, cardiac surgeon and Director of Mechanical Circulatory Assistance, Toronto General Hospital, commented, "Our surgical team is now ready to implant this fourth-generation rotary VAD. We are looking forward to using the Levacor to provide circulatory support to a select group of patients awaiting heart transplant, who have no other therapeutic options." Dr Paul Hendry, cardiac surgeon and Director of the Mechanical Circulatory Support Device Program at the University of Ottawa Heart Institute, added: "Encouraged by the success of the first clinical use of the Levacor VAD in Europe, we are looking forward to providing access to this device to patients for whom conventional therapies have failed or are unsuitable, and to gaining experience with this advanced, fully magnetically levitated system at the Heart Institute."
Mr. Jal Jassawalla, WorldHeart President and CEO, commented, "We have been extremely pleased with the performance of the Levacor VAD in the first two patients in our European feasibility trial. As a result of this experience, we have seen strong worldwide interest from leading clinical centers wishing to participate in clinical trials of the Levacor VAD." The Company is preparing to initiate a U.S. clinical trial in the second half of 2007.
Novacor(R) LVAS Destination Therapy Study Discontinued
Consistent with its previously announced restructuring plans, WorldHeart has elected to terminate enrollment in the RELIANT Trial of its first-generation Novacor LVAS. The company has notified the U.S. Food and Drug Administration that it will voluntarily terminate the Investigational Device Exemption (IDE) for the trial. Dr. Piet Jansen, Chief Medical Officer for WorldHeart, stated: "It has become evident that, with the positive trend in the industry toward next-generation technology, continuing enrollment in the randomized trial for the first-generation pulsatile VAD in accordance with the approved IDE is impractical, and not in the best interest of the Company. Our clinical advisors support our focus on clinical trials with our next-generation rotary VAD." Dr. Jansen added, "WorldHeart will continue to commercially distribute and provide clinical and technical support for the Novacor LVAS under its bridge-to-transplant (BTT) indication for use in the US, as well as for BTT and Destination Therapy in the EU." The Novacor LVAS has been implanted in more than 1700 patients worldwide over more than 22 years of clinical use, and the system remains the most durable and reliable pulsatile VAD available today for end-stage heart failure patients that are eligible for mechanical circulatory support. Remarked Mr. Jassawalla, "We are proud of the contributions that the Novacor LVAS has made over the past 20 years. It has played a key role in validating the clinical viability of multi-year mechanical circulatory support, and has helped pave the way for the clinical introduction of next-generation VADs."
About the Levacor VAD
The Levacor VAD is a fourth-generation rotary VAD. It is the only bearingless, fully magnetically levitated implantable centrifugal rotary pump in clinical trials. An advanced, continuous-flow pump, the Levacor uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing. The proprietary levitation technology employs a unique arrangement of magnetics expected to provide optimal system simplicity and reliability. In contrast to pumps with blood-immersed mechanical or hydrodynamic bearings, full magnetic levitation eliminates wear within the pump and dependence on blood properties for rotor suspension, and is expected to provide improved blood handling by allowing greater clearances around the rotor and more idealized flow patterns across a wider range of operation. The Levacor VAD has been designed with the objective of addressing the needs of future heart failure patient populations with a high safety profile and robust operation.
About World Heart Corporation
WorldHeart is a developer of mechanical circulatory support systems with leading next-generation technologies. 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 are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements regarding the Company's expectations with respect to the Company's future development plans for its next-generation Levacor VAD, including the timing and scope of clinical trials, as well as, 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: continued slow market acceptance of and a shift in market demand away from the Company's Novacor LVAS product; completion of the previously announced $14.1 Million private placement and need for additional financing in the future; costs and delays associated with clinical trials of the Levacor VAD; limitations on third-party reimbursement; inability to protect proprietary technology; continued slower Destination Therapy adoption rate for VADs; delays in completion of cost reductions programs associated with the previously announced restructuring plan; 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, as amended.
World Heart CorporationCONTACT: Richard Juelis, +1-510-563-4713, or Peggy Allman,+1-510-563-4721, both of the World Heart Corporation
Web site: http://www.worldheart.com/
