Thoratec Announces FDA Approval Of HeartMate II(R) For Bridge To Transplantation

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 22 Apr 2008 - 0:00 PDT

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Thoratec Corporation (Nasdaq: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said that it has received FDA approval of its PMA (PreMarket Approval) application, allowing the use of its HeartMate II LVAS (Left Ventricular Assist System) as a bridge-to-transplantation (BTT) in patients suffering from advanced-stage heart failure.

The approval follows a successful clinical trial involving more than 450 BTT patients, including those enrolled under Continued Access Protocols, and a unanimous recommendation for approval from the FDA Circulatory System Devices Advisory Panel last November.

"The HeartMate II is the first continuous flow device to receive FDA approval for this intended use in the U.S., representing a milestone in the treatment of advanced-stage heart failure patients and for the clinicians who treat them," said Gary F. Burbach, president and chief executive officer of Thoratec. "As our clinical trial indicated, the HeartMate II represents a new era in the treatment of advanced-stage heart failure with data demonstrating excellent survival rates, quality of life and functional capacity for a broad range of patients. This patient experience has created a high level of enthusiasm for the HeartMate II within the clinical community. We are hopeful that the device's trial experience, ease of implantation, small size and ability to provide longer duration support will result in broader adoption of mechanical circulatory support for the treatment of these patients," he added.

The approval was based on one-year follow-up data from the first 194 HeartMate II BTT patients enrolled in the trial. Highlights of the data included in the final PMA submission included:

-- The median duration of support was 132 days, and the cumulative patient support in the trial was 109 years.

-- Survival to cardiac transplantation, recovery or ongoing on HeartMate II support was 80 percent at six months and 77 percent at one year.

-- Eighty four percent of the patients survived to hospital discharge or transplantation.

-- Significant improvements were observed across all measures of functional status and quality of life as compared to baseline status.

-- The incidence of major adverse events with comparable definitions -- including infections, strokes and bleeding requiring surgery -- was significantly lower than what was clinically observed in the previous BTT study of the HeartMate VE LVAS.

The approval allows the HeartMate II to be used to treat small patients (BSA < 1.5) based on body habitus if the treating clinician believes that the patient could benefit from the device. In addition, Thoratec will conduct a post-market study that includes a concurrent comparator. The study will follow 169 HeartMate II patients until outcome, or one year -- whichever comes first -- and gather data regarding survival, adverse events, patient gender, small patients and anticoagulation levels.

"With this BTT approval, we will now initiate our sales and marketing programs designed to place the HeartMate II in transplant centers that did not participate in the clinical trial. Our hope is to add about 40 new centers during the balance of the year, which would bring the total number of centers implanting the HeartMate II to approximately 80 centers.

"The foundation of this effort is a strong training program and support materials that provide best practices on patient selection, device implantation and patient discharge and follow-up to ensure optimal patient outcomes. In addition, we are implementing programs to educate referring cardiologists about the compelling data from our trial and to increase their understanding of and appreciation for the value of mechanical circulatory support available with the HeartMate II," Burbach continued.

"For a population having an unmet need and for which drug therapies have not proven to be an effective solution, we believe the HeartMate II represents a breakthrough therapy and new hope for these patients. It further demonstrates our leadership position in the mechanical circulatory support arena with the broadest portfolio of devices. We want to acknowledge the efforts of the clinicians and patients who participated in this landmark trial in making this day a reality," Burbach commented.

About HeartMate II

The HeartMate II is a mechanical circulatory support device intended for a broad range of advanced-stage heart failure patients. An axial flow device, the HeartMate II can pump up to 10 liters of blood per minute, the full output of a healthy heart, and is designed to provide long-term cardiac support. The device is implanted alongside a patient's native heart and takes over the pumping ability of the weakened heart's left ventricle. It is easier to implant than prior devices, and with only one moving part, the HeartMate II is designed to provide exceptional reliability and improved patient quality of life. The device is designed to have a much longer functional life than the previous generation of devices and to operate more simply and quietly.

About Thoratec

Thoratec is a world leader in therapies to address advanced-stage heart failure. The company's product lines include the Thoratec(R) VAD (Ventricular Assist Device) and HeartMate LVAS with more than 11,000 devices implanted in patients suffering from heart failure. Additionally, its International Technidyne Corporation (ITC) division supplies 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.

Many of the preceding paragraphs 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," "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 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, including for the HeartMate II, 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 of 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, "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.

Thoratec Corporation
http://www.thoratec.com