PLEASANTON, Calif., Nov. 17 Thoratec Corporation (Nasdaq: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said that data released today from the Destination Therapy (DT) pivotal trial for the HeartMate II left ventricular assist system (LVAS) demonstrate that the device achieved statistically superior results over the HeartMate XVE, including survival at two years while remaining free from disabling stroke or the need for reoperation to replace or repair the pump. As treated survival was 58 percent for HeartMate II patients versus 24 percent for the HeartMate XVE patients.
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The data were presented at a late breaking clinical trial session of the 2009 Scientific Sessions of the American Heart Association by Dr. Joseph Rogers of Duke University on behalf of the HeartMate II investigators. The trial data were also published by The New England Journal of Medicine today, in an article written by Dr. Mark Slaughter of the University of Louisville, and Dr. Joseph Rogers and Dr. Carmelo Milano of Duke University, et al.
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The HeartMate II Destination Therapy trial involved 200 patients enrolled at 38 centers who were randomized to the HeartMate XVE on a 2-1 basis, respectively. Forty-six percent of the HeartMate II patients successfully achieved the primary composite endpoint of survival at two years while remaining free from disabling stroke or the need for reoperation to replace or repair the pump versus eleven percent of the XVE patient cohort, on an intent to treat basis. Secondary endpoints in the trial included as treated actuarial survival, adverse events, functional status, patient quality of life, hospitalization and assessment of neuro-cognitive function. Patients enrolled in the trial ranged in age from 26-81 years old, with a median age of 64 years.
"We find the two-year survival data, as well as that related to pump performance, adverse events, quality of life and functional status, to be highly positive. Treating patients with the HeartMate II leads to dramatically improved survival, functional capacity and quality of life beyond any other therapy for advanced-stage heart failure patients. We believe the trial outcomes will drive market adoption of the device once it receives DT approval from the FDA, given the poor outcomes with other treatment options available for these patients," said Gary F. Burbach, president and chief executive officer of Thoratec.
"The outcomes of this study are particularly impressive when you consider the status of these patients at the time they entered the trial," Dr. Slaughter noted. "These patients have a similar profile to those in the REMATCH trial who were managed with the standard of care--optimal medical management--and had a two-year survival rate of eight percent versus the 58 percent achieved by the HeartMate II in this trial," he added.
"The trial outcomes showed that the smaller size of the HeartMate II enables its use in a broader patient population, including the currently under-served population of small sized patients with advanced-stage heart failure, most notably women. They also demonstrated superior safety profiles for the HeartMate II, based on the level of major adverse events, including reduced rates of infection, renal failure, right heart and respiratory failure and cardiovascular arrhythmia. HeartMate II patients also fared better with respect to shorter hospital stays and lower rates of re-hospitalizations and reoperations per year," Burbach added.
Burbach noted that at two years of support, 80 percent of the HeartMate II patients were NYHA Class I or II compared to zero at baseline, and there was a doubling of the distance a patient could walk. Improvements over baseline in the HeartMate II patients were statistically significant in all quality of life and functional measures.
"There is an unmet need among thousands of patients annually with advanced-stage heart failure who are ineligible for cardiac transplantation and do not benefit from medical therapy. For these patients with limited treatment options, the HeartMate II is a therapy that can provide long-term hemodynamic support that is also linked to significant improvements in longevity and quality of life," Dr. Rogers said.
The HeartMate II was approved for Bridge-to-Transplantation (BTT) in the U.S. in April 2008, and the HeartMate XVE is the only device approved by the FDA for both DT and BTT. A continuous flow device, the HeartMate II is an implantable LVAS powered by a rotary pumping mechanism and is designed to have a much longer functional life than pulsatile devices and to operate more simply and quietly. The device provides blood flow through the circulatory system on a continuous basis with only one moving part. It is also smaller and easier to implant than a pulsatile device.
The company will hold a webcast of its investor meeting at the American Heart Association to discuss the data. The event begins at 1:30 p.m., Eastern Standard Time (10:30 a.m., Pacific Standard Time), today, November 17, and can be accessed through the company's website at http://www.thoratec.com.
Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's product lines include the Thoratec® VAD (Ventricular Assist Device) and HeartMate LVAS with more than 14,000 devices implanted in patients suffering from heart failure. Additionally, its International Technidyne Corporation (ITC) division is a leader in point-of-care 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.
Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation, and IVAD is a trademark of Thoratec Corporation. ITC, A-VOX Systems, AVOXimeter, HEMOCRHON, ProTime and IRMA are registered trademarks of International Technidyne Corporation. CentriMag is a registered trademark of Levitronix LLC.
Many of the preceding paragraphs, particularly but not exclusively those addressing future performance or timelines for regulatory approvals, 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, "believes," "views," "expects," "plans," "hopes," "could," "will," 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 regulatory approvals, 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 existing markets for our products, the results of enrollment in and timing of clinical trials, the effects of FDA regulatory requirements and the effects of healthcare reimbursement and coverage policies. 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, "Risk Factors," in Thoratec's most recent annual report on Form 10-K, and in Thoratec's first quarter 2009 quarterly report on Form 10-Q, and as may be updated in subsequent SEC filings. 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.
SOURCE Thoratec Corporation
