Healthcare Industry News: LVAS
News Release - May 15, 2006
WorldHeart's Next-Generation Rotary VAD Successfully Implanted in Second PatientFirst Patient Continues to Recover
Achievement Reinforces Competitive Position
U.S. Trial to Begin in Early 2007
OAKLAND, Calif., May 15 (HSMN NewsFeed) -- World Heart Corporation (Nasdaq: WHRT, TSX: WHT) (WorldHeart), a global technology leader in mechanical circulatory support systems, announced today that the second human implant of its advanced rotary ventricular assist device (VAD) took place on May 10, 2006.
"We are very pleased with this expansion of clinical use of our advanced rotary VAD system and the performance of our rotary VAD in both of these patients to date," said Jal S. Jassawalla, WorldHeart's President and Chief Executive Officer. "The first implanted device continues to perform failure-free and there have been no adverse events. We remain committed to initiating a U.S. clinical trial of the rotary VAD in early 2007."
The first patient in the feasibility clinical trial of WorldHeart's next-generation rotary VAD has been supported for more than two months and he continues to progress well on the VAD. He celebrated Easter outside the hospital surrounded by family and friends.
"The surgical and clinical team at St. Luke's is gratified to see the progress in health status and quality of life of our first patient," 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. "We are pleased to offer this technology to the second patient in this important study."
Mr. Jassawalla added, "Our rotary VAD has been previewed at several clinician meetings in the United States, and we have been extremely encouraged by the response and stated eagerness to begin implanting patients with this advanced rotary VAD.
"We are pleased with the breadth of our product portfolio and our opportunity to lead the mechanical circulatory support industry," said Mr. Jassawalla. "We believe that over time we will continue to make a significant contribution to this industry and create value for our shareholders."
WorldHeart Competitive Position
More than 550,000 new cases of heart failure will be diagnosed in the United States in the next twelve months, according to the American Heart Association. WorldHeart's strategy is to provide the most reliable, long-term mechanical circulatory support to the broadest population of heart failure patients. The ongoing successful clinical trial of its Rotary VAD is a significant step towards establishing a product platform to address that need. "We believe that our field needs both pulsatile and rotary pumps to treat the whole spectrum of clinical needs of end-stage and late-stage heart failure patients," commented Mr. Jassawalla. "As the only company with both rotary and pulsatile next-generation VADs under development, WorldHeart is uniquely positioned to address the full spectrum of heart failure patients requiring long-term support."
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. 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. Full magnetic levitation avoids 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.
WorldHeart's current NovacorŪ 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 provided patient support for up to six years. Enrollment in the RELIANT trial has increased significantly this year to competitive levels. The recently approved modifications to broaden the inclusion criteria and reduce the trial size almost in half, are expected to accelerate trial completion and potential commercial availability for DT in the US. The next-generation Novacor II pulsatile LVAS is based on the proven technology of the Novacor LVAS, but is smaller, lighter and quieter. The new pump is driven by direct magnetic actuation, eliminating bearings and other components subject to wear. Currently in the animal trial phase, this bearingless design is expected to provide enhanced long-term durability, with a projected lifetime of 8 to 10 years.
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 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 and 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 and Quarterly Report on Form 10-QSB for the quarter ended March 31, 2006.
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