OAKLAND, Calif., March 26 /PRNewswire-FirstCall/ -- - World Heart Corporation, a technology leader in mechanical circulatory support systems, announced today that it has assembled a Clinical Trial Coordinating Committee to direct the US clinical trial of the Levacor(TM) rotary ventricular assist device (VAD), expected to begin later this year. The members of this committee will provide leadership and clinical direction for the trial by developing the study protocol, and working with clinical colleagues to share best practices, address clinical issues and assist with the timely completion of the trial.
Committee members include: Dr. James W. Long, cardiovascular surgeon, Director of the Utah Artificial Heart Program at LDS Hospital and Adjunct Associate Professor, Department of Bioengineering, University of Utah, Salt Lake City, Utah. He is currently President of the American Society for Artificial Internal Organs. Dr. Stephanie Moore, cardiologist, Assistant in Medicine at Massachusetts General Hospital and Instructor, Harvard Medical School, Boston, Massachusetts. Her scope of practice includes immediate and extended mechanical assist device therapy, cardiac resynchronization therapy and transplantation. She participates in the ISHLT, HFSA and ASAIO, and has lectured nationally and internationally on innovative advanced heart failure therapies. Dr. John B. O’Connell, cardiologist, Director of the Center for Heart Failure, Bluhm Cardiovascular Institute and Professor of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois. He has held numerous scientific leadership positions, including President of the International Society for Heart and Lung Transplantation and the Association of Professors of Medicine. Dr. Francis D. Pagani, cardiovascular surgeon, Associate Professor of Surgery and Director, Adult Heart Transplantation and Artificial Devices Program, Section of Cardiac Surgery, University of Michigan Medical Center, Ann Arbor, Michigan. Dr. Mark S. Slaughter, cardiovascular surgeon, Director of the Mechanical Assist Device Program and Surgery for Congestive Heart Failure at Advocate Christ Medical Center, Oak Lawn, Illinois. Dr. Randall C. Starling, cardiologist, Professor of Medicine, Section Head of Heart Failure and Cardiac Transplant Medicine at the Cleveland Clinic and Medical Director of the hospital’s Kaufman Center for Heart Failure, Cleveland, Ohio. He is a member of the Board of Directors of the International Society of Heart and Lung Transplantation, and serves on the Guidelines Committee of the Heart Failure Society of America.
Mr. Jal Jassawalla, WorldHeart President and CEO, commented, “We are pleased to have the support of these distinguished clinicians, and excited about the anticipated clinical use of the Levacor in the US. WorldHeart is now the only experienced VAD manufacturer actively developing a next- generation, bearingless, fully magnetically levitated centrifugal device. Based on the unique design of this VAD and our initial clinical success in Greece, we anticipate that the upcoming US trial will validate the advantages, to the patients, of this advanced technology.”
Levacor Clinical Trials
The US clinical trial will begin with a feasibility study as a bridge to cardiac transplantation (BTT), planned to start in the fourth quarter of this year. A subsequent pivotal study is expected to result in market clearance of the device for both BTT and Destination Therapy. The US study follows an initial feasibility trial in Greece, in which the device was successfully used to treat two patients as a bridge to recovery of the diseased native heart. Two hospitals in Canada -- Toronto General Hospital and the University of Ottawa Heart Institute -- are currently approved to implant the Levacor rotary VAD as a bridge to cardiac transplant under Health Canada’s Therapeutic Product Directorate Special Access Program.
Dr. Pagani said, “We eagerly anticipate gaining access to this unique, next-generation device. We believe its use of a bearingless, magnetically levitated rotor provides the potential for superior blood handling characteristics, range of operation and margin of safety.”
Dr. O’Connell stated, “We are looking forward to participating in the US trial of the Levacor VAD. We are also excited to be participating in the design of an innovative pivotal clinical study protocol, which is expected to reduce the duration of the trial, number of patients to be studied and the time needed to attain marketing approval.”
“We are pleased to have assembled such an outstanding team of clinicians to help direct this important study,” said Dr. Piet Jansen, Chief Medical Officer of WorldHeart. “With their support and guidance, we anticipate that this study will represent a significant advancement in the field of mechanical circulatory support, while making this potentially life-saving therapy available to a wider population of heart failure patients.”
About the Levacor VAD
The Levacor VAD is a next-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 as well as dependence on blood properties for rotor suspension, and is expected to provide improved blood compatibility 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 current and future heart-failure patient populations with a high safety profile and robust range of 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 Heesch, The 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: delays in development, preclinical qualification and regulatory approvals of the Levacor VAD; costs and delays associated with clinical trials; limitations on third-party reimbursement; inability to protect proprietary technology; continued slower Destination Therapy adoption rate for VADs; need for additional financing; and other risks detailed in the Company’s filings with the United States Securities and Exchange Commission, including its Current Report on Form 8-K filed on December 22, 2006 and its upcoming Annual Report on Form 10-KSB for the year ended December 31, 2006.
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//
