OAKLAND, Calif., Feb. 15 /PRNewswire-FirstCall/ -- World Heart Corporation , a global technology leader in mechanical circulatory support systems, today announced that it received regulatory authorization from the Greek Ministry of Health to proceed with its rotary ventricular assist device (VAD) feasibility clinical trial. The Greek surgical team successfully completed technical and clinical training at WorldHeart’s Rotary Systems operations located in Salt Lake City, Utah. The clinical trial is expected to begin imminently, pending completion of the final elements of the preclinical verification and validation procedures.
Greek Ministry of Health Authorization
The Company obtained authorization from the National Organization for Medicines (EOF), the division of the Greek Health Ministry responsible for monitoring the conduct of medical device clinical trials, to begin human implants of the rotary VAD. The study protocol was approved by the Ethics Committee at St. Luke’s Hospital in Thessaloniki, Greece, in November 2005.
Jal S. Jassawalla, WorldHeart’s President and Chief Executive Officer said, “We are pleased with the progress made in the pre-clinical development of our advanced rotary system, and that readiness for its evaluation in the European feasibility trial is on schedule. Integration of our Rotary Systems operations, acquired last year from MedQuest Products, Inc., has proceeded rapidly. 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 long-term needs of patients across a wide spectrum of heart failure conditions.”
On-Site Clinical Training Completion
A team of cardiac surgeons and perfusionists from St. Luke’s Hospital, Thessaloniki, participated in the training last week, which was conducted at WorldHeart’s laboratories, the University of Utah and at LDS Hospital, all located in Salt Lake City, Utah.
Dr. Antonis Pitsis, cardiac surgeon and Director of the Thessaloniki Heart Institute at St. Luke’s and the principal clinical investigator of the feasibility trial, commented, “Our surgical team is now ready to conduct the clinical trial for this well-designed rotary VAD. We are looking forward to using the WorldHeart rotary system to provide circulatory support to a select group of patients.”
Dr. Petros Sfirakis, Deputy Director of Cardiac Surgery at the Onassis Cardiac Surgery Center, Athens, Greece, also participated in the training. The Onassis Cardiac Surgery Center has experience with WorldHeart’s CE-marked Novacor pulsatile VAD and will collaborate with St. Luke’s in the initial clinical trial of the WorldHeart rotary VAD.
WorldHeart Rotary VAD
The WorldHeart rotary VAD will be the only bearingless, fully magnetically levitated centrifugal rotary pump in clinical trials. It is an advanced, next-generation, continuous flow pump that uses magnetic levitation to fully suspend the spinning impeller, its only moving part, inside a compact housing. The pump’s proprietary levitation technology employs a unique combination of passive magnetic suspension and single-axis active control, which is expected to provide optimal system simplicity and reliability.
Unlike most rotary pumps currently in clinical trials, it does not rely on either a mechanical bearing or a film of blood (blood bearing) to support the impeller. Relative to pumps with blood or mechanical bearings, full magnetic levitation eliminates wear mechanisms within the pump and is expected to provide improved blood compatibility by allowing greater clearances and more favorable, obstruction-free, blood flow around the impeller.
About World Heart Corporation
World Heart Corporation is a 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.
Any forward-looking statements in this release including those about 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 preclinical testing and planned clinical trials; possibility of unsuccessful results in initial feasibility studies with the rotary VAD 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/