Thoratec Comments on Publication of HeartMate II® Bridge-to-Transplantation Post-Approval Study in JACC

PLEASANTON, Calif., May 3, 2011 /PRNewswire/ -- Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today commented on an article published in the Journal of the American College of Cardiology (JACC) examining outcomes from a bridge-to-transplantation (BTT) post-approval study featuring the company's HeartMate II® LVAS (Left Ventricular Assist System).  The article's lead authors include Dr. Randall Starling from Cleveland Clinic, Dr. Yoshifumi Naka from Columbia Presbyterian Hospital, and Dr. Andrew Boyle from Aurora St. Luke's Medical Center.

Results from the study showed survival for patients on HeartMate II in the commercial setting of 90 percent at six months and 85 percent at one year. Additionally, the study found meaningful improvements in important adverse event categories when compared to a similar group of patients implanted with other approved LVADs. In particular, HeartMate II patients experienced extremely low occurrences of some of the most critical adverse events, including pump replacement, stroke, and right heart failure.

The HeartMate II received FDA approval for BTT in April 2008. The post-approval study was designed to assess whether the commercial use of the HeartMate II was comparable to other available commercial devices approved for BTT and to validate the findings from the pivotal clinical trial regarding the efficacy and risk profile of the HeartMate II.

The FDA-sanctioned post-approval study compared outcomes from the first 169 post-approval HeartMate II BTT patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) in the U.S., versus 169 patients who were treated with either the HeartMate® XVE or Thoratec® IVAD™ (Implantable Ventricular Assist Device). Patients were enrolled at 77 U.S. centers and followed for at least one year after implant. The primary endpoint was survival while awaiting transplantation, with secondary endpoints including adverse events, functional status and quality of life. Enrollment of HeartMate II patients in the study occurred from April 2008 through August 2008.

For the HeartMate II patients, 62 percent were classified as INTERMACS profile I or II, representing the sickest end-stage heart failure patients, including almost 25 percent in profile I.  INTERMACS profile I describes patients in critical cardiogenic shock, while INTERMACS profile II captures patients in progressive decline on inotropes.

"The results for HeartMate II in this challenging patient population are highly compelling, not only in terms of absolute survival but also with respect to quality of life and continued reductions in adverse events," said Gary F. Burbach, president and chief executive officer of Thoratec. "In particular, we were pleased with the extremely low rates of device replacement and stroke, validating the favorable thrombotic profile and flexible patient management strategies facilitated by the device," he added.

Key findings for the HeartMate II study population were as follows:

• Kaplan-Meier survival was 90 percent at six months and 85 percent at one year.
• 91 percent of patients achieved a successful outcome of transplant, cardiac recovery or ongoing LVAD support at six months.
• Device replacement occurred at a rate of 0.01 events per patient-year over the duration of the study. No patients required a pump replacement during the first six months of support.
• The total stroke rate was 0.08 events per patient-year.
• Only 3 percent of patients developed right heart failure requiring a right ventricular assist device.  
• Rates of bleeding, infection, respiratory failure, and renal failure, among others, demonstrated meaningful improvements when compared to earlier published clinical trial results.

"The results of this post-approval study support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HeartMate II LVAD in a post-market approval 'real world' BTT population.  The results also show encouraging improvement in outcomes with the device in commercial use since completion of the clinical trial," the authors noted in the article.  "Surprisingly, as the HeartMate II device became available outside of the controlled context of a clinical trial, excellent results were maintained or perhaps surpassed."  

"We look forward to sharing these results, which have been incorporated into the HeartMate II label, as well as the positive outcomes we are seeing with the HeartMate II for Destination Therapy patients, as part of our efforts to educate the clinical community and to foster greater appreciation for the value of mechanical circulatory support in treating advanced-stage heart failure patients," Burbach said.

About HeartMate II

The Thoratec HeartMate II Left Ventricular Assist Device (LVAD) is a mechanical circulatory support (MCS) device intended for a broad range of advanced-stage heart failure patients. HeartMate II is designed to restore blood flow and to improve survival, functional status, and quality of life. The HeartMate II, implanted alongside a patient's native heart, is designed to take over the pumping ability of the weakened heart's left ventricle, which is responsible for pumping oxygen-rich blood from the lungs throughout the body. HeartMate II is the only continuous flow LVAD that is FDA approved for both bridge-to-transplantation and destination therapy, or long-term, support.

About Thoratec

Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's products include the HeartMate LVAS and Thoratec VAD, with more than 18,000 devices implanted in patients suffering from heart failure. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's web site at http://www.thoratec.com.

Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation and IVAD is a trademark of Thoratec Corporation.

Many of the preceding paragraphs, particularly but not exclusively those addressing the performance of the company's devices in the clinical trial or commercial setting, contain forward-looking statements within the meaning of Sections 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," "projects," "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 of these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to regulatory approvals, customer and physician acceptance of Thoratec products 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 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