Healthcare Industry News: vascular access
News Release - March 1, 2006
Thoratec Says New HFSA Guidelines Reflect Growing Acceptance of VADs for Treating Heart Failure PatientsPLEASANTON, Calif., March 1 (HSMN NewsFeed) -- Thoratec Corporation (Nasdaq: THOR ), a world leader in products to treat cardiovascular disease, said today that new heart failure practice guidelines issued by the Heart Failure Society of America (HFSA) for the first time recommend Ventricular Assist Devices (VADs) as a bridge-to-transplantation and for permanent long-term support.
The guidelines were published in the February issue of the Journal of Cardiac Failure. They noted that VADs should be considered as a bridge-to-transplantation for patients awaiting heart transplantation who have become refractory to all means of medical management and for patients with severe forms of heart failure who are not candidates for transplantation -- known as Destination Therapy -- particularly those who cannot be weaned from intravenous drug support.
The American College of Cardiology (ACC) and American Heart Association (AHA) issued similar guidelines regarding the use of VADs in September 2005.
"The new HFSA guidelines, along with those issued by ACC and AHA, validate the need for alternative forms of therapy for advanced-stage heart failure patients and that VADs represent a viable option for long term or permanent support," noted Gary Burbach, president and chief executive officer of Thoratec. "These principles reflect the value of VADs in the delivery of hemodynamic restoration therapy and increasing recognition of how advances in technology and patient management are leading to improved survival rates and enhanced patient quality of life," he added.
"These guidelines represent an important step in educating the referral community about the growing body of clinical evidence supporting this therapy. The guidelines also make note of the new advantages of next generation technology. We believe that our HeartMate® II LVAS (left ventricular assist system) is one such device," said Jeffrey Nelson, president of Thoratec's Cardiovascular Division. "The HeartMate II is currently in the midst of a Phase II pivotal trial for both bridge-to-transplantation and Destination Therapy following a successful Phase I trial," he added.
"As a cardiologist specializing in heart failure, I am very pleased to see these new guidelines and the continued discussion of new treatments for this disease, which is the leading cause of death among Americans," noted Dr. Randall Starling, Medical Director, Kaufman Center for Heart Failure at the Cleveland Clinic Foundation. "It is important that primary care physicians understand the improving outcomes we are seeing with respect to survival and quality of life for patients implanted with these devices," added Dr. Starling, who was on the writing committee for the HFSA guidelines.
Thoratec Corporation is a world leader in hemodynamic restoration therapy-developing products to treat cardiovascular disease. The company's product line includes the Thoratec® VAD and HeartMate LVAS with more than 10,000 devices implanted in patients suffering from heart failure. Thoratec's product line also includes the Vectra® VAG (vascular access graft) for patients undergoing hemodialysis. Additionally, its International Technidyne Corporation (ITC) division supplies blood 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 .
Many of the preceding paragraphs, particularly but not exclusively those addressing guidance for future performance or timelines and milestones for clinical trials, contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, "expects," "projects," "hopes," "believes," "could," and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec's control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to the development of new markets including Destination Therapy, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, changes in the mix of Thoratec product sales and the related gross margin for such product sales, the results of clinical trials including the HeartMate II, the ability to improve financial performance, regulatory approval processes, the effects of healthcare reimbursement and coverage policies, the effects of seasonality in Thoratec product sales, the effects of price competition from any Thoratec competitors and the effects any merger and acquisition-related activities. Forward-looking statements contained in this press release should be considered in light of these factors and those factors discussed from time to time in Thoratec's public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, "Factors That May Affect Future Results," in Thoratec's most recent annual report on Form 10-K and quarterly report on Form 10-Q. 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.
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