Healthcare Industry News: rotary ventricular assist device
News Release - March 14, 2006
First Human Implant of WorldHeart's Next-Generation Rotary VADClinical Trial Initiated in Europe
OAKLAND, Calif., March 14 (HSMN NewsFeed) -- World Heart Corporation (WorldHeart) (Nasdaq: WHRT, TSX: WHT), a global technology leader in mechanical circulatory support systems, announced today that the first human implant of its advanced rotary ventricular assist device (VAD) took place on March 8, 2006. The successful implant, performed at St. Luke's Hospital, Thessaloniki, Greece, marks the start of the feasibility clinical trial of WorldHeart's next-generation rotary VAD.
A surgical team, whose members had completed training at WorldHeart's Salt Lake City facility last month, successfully implanted the device into a 67-year-old man with advanced congestive heart failure, as part of an operation that included heart valve repair as well as a coronary artery bypass graft.
Initial Rotary VAD Implant
"Our surgical and clinical team is extremely pleased to perform the first implant of this unique new device," said Dr. Antonis Pitsis, cardiac surgeon and Director of the Thessaloniki Heart Institute at St. Luke's Hospital, and principal clinical investigator of the feasibility trial. "The WorldHeart rotary VAD has, thus far met our high expectations and it has been particularly rewarding to see the patient doing well. The patient is enjoying interacting with his family."
Dr. James Long, cardiac surgeon and Director of the Utah Artificial Heart Program at LDS Hospital in Salt Lake City, Utah, assisted on the operation. Dr. Long said, "It is encouraging to see the field of long-term mechanical circulatory support expand with exciting new technologies being utilized in new high quality centers worldwide. I believe growth of the field will be enhanced by the introduction and validation of such next-generation devices designed for ease of use, enhanced quality of life and improvements with performance, blood compatibility and durability."
Dr. Petros Sfirakis, Deputy Director of Cardiac Surgery at the Onassis Cardiac Surgery Center, Athens, Greece, also assisted with the operation. The Onassis Cardiac Surgery Center has experience with WorldHeart's CE-marked Novacor pulsatile VAD and is collaborating with St. Luke's in the initial clinical trial of the WorldHeart rotary VAD.
Jal S. Jassawalla, WorldHeart's President and Chief Executive Officer said, "We are pleased with the successful first clinical use of our advanced rotary system, starting our European feasibility trial on schedule. This is a significant milestone in the development and commercialization of our next-generation products, and it supports our goal of meeting the long-term needs of patients across a wide spectrum of heart failure conditions, with both rotary and pulsatile VADs."
WorldHeart Rotary VAD
The WorldHeart rotary VAD is the only bearingless, fully magnetically levitated implantable centrifugal rotary pump in clinical trials. It is an advanced, next-generation, continuous flow pump that uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing. The pump's proprietary levitation technology employs a 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 rotor. 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 rotor.
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. WorldHeart is dedicated to working with physicians to provide the most 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 including those about planned 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.
Source: World Heart
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