THOR Synthorx Inc

Thoratec Announces First HeartMate(R) II Implant in U.S. Clinical Trial; Next Generation Assist Device Designed to Provide Long-Term Support PLEASANTON, Calif., Nov. 20 /PRNewswire-FirstCall/ -- Thoratec Corporation , a world leader in products to treat cardiovascular diseases, said today that an 18-year-old man suffering from heart failure has become the first patient to be implanted in the company's U.S. clinical trial for its HeartMate II heart assist device. The HeartMate II is a next generation design intended for long-term cardiac support for patients who are in end-stage heart failure. The procedure took place at the Texas Heart Institute in Houston and was performed by Dr. Bud Frazier, chief of Cardiopulmonary Transplantation and director of Surgical Research at the Texas Heart Institute, and chief of the Transplant Service at St. Luke's Episcopal Hospital. "This is a major clinical milestone for Thoratec as the HeartMate II is the company's first axial flow device to enter human trials in the U.S. We understand the procedure went very well and the patient is recovering quite rapidly," said D. Keith Grossman, president and chief executive officer. "The device incorporates a simple and elegant design and incorporates enhanced control software and other improvements based on our early clinical experience in Europe. Because of its small size, the HeartMate II is suitable for a wider range of patients, including small adults and children," he added. "We have a high level of regulatory and clinical activity currently underway at the company. In addition to the launch of this trial and near-term initiation of a trial for the HeartMate II in the United Kingdom, we are preparing a filing for FDA approval of the Thoratec(R) IVAD (Implantable Ventricular Assist Device) and completed the initial enrollment in our European trial for the Aria(TM) CABG (coronary artery bypass graft)," he continued. The HeartMate II is an implantable LVAS (left ventricular assist system) consisting of a rotary blood pump that is designed to provide long-term support. It weighs approximately 12 ounces and is approximately 1.5 inches in diameter and 2.5 inches long. In addition to being significantly smaller than currently approved devices, with only one moving part, the HeartMate II is designed to operate more simply and quietly than other approved devices. As an axial flow device, the HeartMate II provides blood flow through the circulatory system on a continual basis, and is smaller and easier to implant than pulsatile devices. A unique feature of the device is its automatic speed control mode that is designed to regulate pumping activity based on different levels of patient or cardiac activity. Other devices in clinical evaluation must be manually adjusted. "The operation was technically flawless and the technology worked efficiently without complications," Dr. Frazier said. "The patient is now out of the ICU and is ambulatory, which is pivotal considering how near death he was. This is an important advance for all end-stage heart failure patients, especially for the smaller patients who are currently not supportable by the larger pump technology," he continued. This safety and early efficacy trial will begin with seven patients at four centers, and the device will be evaluated initially for use as a bridge to heart transplantation. "Response to this trial among clinicians has been very positive and we are hopeful that enrollment in Phase I of this trial will proceed in a timely manner," said Jeffery Nelson, president of Thoratec's cardiovascular division. "Our agreement with the FDA is to utilize the follow up data from this phase of the trial to seek approval for an expanded study-something we hope can occur by early next year," he added. Thoratec Corporation is a world leader in products to treat cardiovascular disease with its Thoratec(R) VAD (ventricular assist device) and HeartMate LVAS implanted in more than 6,000 patients suffering from heart failure. Thoratec's product line also includes the Vectra(R) vascular access graft (VAG) for patients undergoing hemodialysis. Additionally, its International Technidyne Corporation (ITC) division supplies blood coagulation testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web sites at http://www.thoratec.com/ or http://www.itcmed.com/ . The portions of this news release that relate to future plans, events or performance are forward-looking statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to the results of clinical trials, regulatory approval processes, healthcare reimbursement and coverage policies and acquisition activities. These factors, and others, are discussed more fully under the heading, "Risk Factors," in Thoratec's 10-K for the fiscal year ended December 28, 2002, and other filings with the Securities and Exchange Commission. Actual results, events or performance may differ materially. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. DATASOURCE: Thoratec Corporation CONTACT: investors, Wayne Boylston, Chief Financial Officer of Thoratec Corporation, +1-925-847-8600; or media, April Grefthen, +1-310-577-7870, ext. 165, or , or Jakob Jakobsen, +1-310-577-7870, ext. 161, or , both of FischerHealth, Inc. for Thoratec Corporation Web site: http://www.thoratec.com/

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