OAKLAND, Calif., Nov. 16 /PRNewswire-FirstCall/ -- World Heart Corporation , a global technology leader in mechanical circulatory support systems, today announced that data from its INTrEPID study was presented at the 2005 Scientific Sessions of the American Heart Association meeting in Dallas.
The INTrEPID study (Investigation of Non-Transplant Eligible Patients who are Inotrope Dependent) investigated whether the Novacor(R) LVAS (Left Ventricular Assist System) reduces mortality and improves quality of life in patients with severe end-stage heart failure who are not eligible for a heart transplant. The study results show that patients receiving a Novacor LVAS had an average survival time more than three times longer than control patients who received optimal medical therapy but no device. In addition, patients who were on the LVADs scored significantly higher on standard measures of quality of life than patients in the control group.
Duke University cardiologist Joseph Rogers, M.D., who presented the trial results, commented that “Patients who received the devices not only had a lengthened quantity of life, but they appeared to have an improved quality of life. This is a remarkably ill group of patients, and when you look at the control group, which was receiving the best care medicine has to offer, we can only keep ten percent of them alive after one year.” Two LVAS recipients from the INTrEPID are currently supported after more than four years, on their original devices.
“The study data is consistent with the world-wide Novacor experience,” said Piet Jansen, M.D., WorldHeart’s Chief Medical Officer. “Patients on LVAS support commonly return to home and to work, leading normal, active lives. Individuals have been successfully supported for as long as six years.”
Following upon the INTrEPID feasibility study, WorldHeart is currently conducting a pivotal randomized study comparing the Novacor LVAS to an approved Destination Therapy device. The objective of the RELIANT trial (Randomized Evaluation of the Novacor(R) LVAS In A Non-Transplant Population) is to demonstrate that use of the Novacor LVAS is superior to optimal medical therapy by demonstrating equivalence to the HeartMate XVE LVAS, which has been evaluated and approved for such use. The Novacor LVAS has Category B4 status under the existing IDE, permitting reimbursement by the Centers for Medicare and Medicaid Services for implants within the trial. Data from this study is expected to support a Pre-market Approval Supplement that will request approval for use of the Novacor LVAS by non-transplant eligible patients (Destination Therapy). To date, twenty centers have enrolled in the RELIANT trial with several additional centers in the enrollment process. Nineteen patients have been enrolled in the study at ten centers.
About the 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 21 years of clinical use. The Novacor LVAS has unprecedented reliability and durability. 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 USA 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 technology leader headquartered in Oakland, California, USA with additional facilities in Heesch, Netherlands and in Salt Lake City, Utah. 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; inconsistent and difficult to predict use of the Company’s Novacor LVAS product; costs and delays associated with government regulation; limitations on third-party reimbursement; inability to protect proprietary technology; potential product liability; slower destination therapy adoption rate for VADs including our Novacor LVAS; 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/
