Healthcare Industry News: LVAS
News Release - June 29, 2006
WorldHeart Rotary VAD Implant a SuccessFirst Human Patient Goes Home
U.S. Trial of Next-Gen Ventricular Assist Device Anticipated in 2007
OAKLAND, Calif., June 29 (HSMN NewsFeed) -- World Heart Corporation (Nasdaq: WHRT, TSX: WHT) (WorldHeart), a global technology leader in mechanical circulatory support systems, announced today that the first patient implanted with its advanced ventricular assist device (VAD) went home last week. He was discharged from the hospital after the VAD was explanted, having recovered sufficient cardiac function to restore him to a good quality of life.
In early March, the Rotary VAD was implanted into a 67-year-old man with end-stage, Class IV heart failure, as part of an operation that included heart repair and VAD support. The surgery, performed at St. Luke's Hospital, Thessaloniki, Greece, marked the start of the feasibility clinical trial of WorldHeart's next-generation Rotary VAD. Since then, a second patient has been successfully implanted with the Rotary VAD and continues to recover.
"The very positive clinical outcome for the first patient more than met our expectations for the trial," said Dr. Antonis Pitsis, Principal Investigator from St. Luke's Hospital. "While supported by the VAD, he regained cardiac functionality such that he no longer requires mechanical ventricular assistance."
Jal S. Jassawalla, WorldHeart's President and Chief Executive Officer, commented, "We are extremely pleased with the way our device is performing in this European feasibility trial, and look forward to initiating a United States trial currently planned for early next year. Cardiac surgeons and cardiologists are eager to begin evaluating our advanced Rotary VAD in their patients."
WorldHeart Provides Pulsatile and Rotary Solutions for Heart Failure Patients
WorldHeart's strategy is to provide reliable, long-term mechanical circulatory support to the broadest population of heart failure patients. WorldHeart is developing both pulsatile VADs, which mimic the action of the natural heart, as well as the continuous flow Rotary VAD, which is smaller and more easily implanted.
"We believe the differing requirements of late- and end-stage heart failure patients define a need for both pulsatile and rotary heart pumps. No single technology fits all patients," said Mr. Jassawalla. "Our product portfolio, including both a commercially available pulsatile pump and next- generation pulsatile and rotary VADs in development, positions us very well to address the full spectrum of heart failure patients requiring long-term support."
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 impeller, its only moving part, inside a compact housing. The 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. In contrast 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 obstruction-free, blood flow around the impeller.
The NovacorŪ LVAS
WorldHeart's current commercial product, the Novacor Left Ventricular Assist System (LVAS), is the most durable and reliable pulsatile VAD in the world today. Approved for Bridge-to-Transplant (BTT) use in the US, and for BTT and Destination Therapy (DT) use in Europe, it has supported patients for as long as 6 years, with individual pumps operating as long as 4.9 years before elective replacement. A clinical trial, known as RELIANT, is now underway to expand the approved US indication for Novacor to include Destination Therapy for patients who are not eligible for transplantation. A next-generation pulsatile pump, the Novacor II, is currently under development.
About World Heart Corporation
WorldHeart is a global technology leader in mechanical circulatory support systems, dedicated to working with physicians to provide reliable, long-term mechanical circulatory support products and services to the broadest patient population through technology, leadership and innovation. The company is headquartered in Oakland, California, 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 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 the Company's ability to adequately finance the product development and commercialization of the Company's products; potential delays in successfully completing preclinical testing and planned clinical trials; possibility of unsuccessful results in subsequent 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 Annual Report on Form 10- KSB, as amended, for the year ended December 31, 2005.
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