As a result of the data, the study's Data Safety Monitoring Board (DSMB)has concurred with Thoratec's plan to eliminate randomization for alladditional patients enrolled in the DT study under the FDA-authorizedContinuous Access Protocol (CAP). The company indicated that it will be filingan Investigational Device Exemption (IDE) Supplement with the FDA seekingapproval for this action later this month, and that it now expects to file aPreMarket Approval (PMA) application seeking commercial approval of theHeartMate II for DT in the first half of 2009.

In May 2007, the company announced that it had achieved the requiredenrollment of 200 patients in the randomized portion of the trial. Since then,the company has continued to enroll patients under CAPs, including the mostrecent CAP approved by the FDA in mid-November allowing for enrollment of anadditional 60 patients. As of October 24, 2008, the company had enrolled 607patients in the trial, including 366 in the randomized portion of the study.

"This is tremendous news for patients suffering from advanced-stage heartfailure and the clinicians who treat them. The data indicate that theHeartMate II achieved statistical superiority to the control group patients byan overwhelming margin. These findings complement the experience with thedevice in bridge-to-transplantation (BTT) patients, both in our pivotal trialand as a commercially available device since receiving FDA approval in April,"noted Gary F. Burbach, president and chief executive officer.

"We are now in the process of providing the conclusions from this analysisto our clinical investigators and the FDA, and would hope to see the initialpublic presentation of data from the trial soon after we file our PMA. As isalways the case, the FDA must review and confirm our findings. We willinitiate this process with our request to end randomization in the ongoing DTtrial later this month. We are extremely gratified to report this clinicaltrial milestone which is a tribute to the clinicians and centers participatingin the study, as well as the entire team at Thoratec," he added.

The HeartMate II is a mechanical circulatory support device intended for abroad range of advanced-stage heart failure patients. A continuous flowdevice, the HeartMate II can pump up to 10 liters of blood per minute and isdesigned to provide long-term cardiac support. The device is implantedalongside a patient's native heart and takes over the pumping ability of theweakened heart's left ventricle. It is easier to implant than prior devices,and with only one moving part, the HeartMate II is designed to provideexceptional reliability and improved patient quality of life. The device isdesigned to have a much longer functional life than the previous generation ofdevices and to operate more simply and quietly.

Thoratec is a world leader in therapies to address advanced-stage heartfailure. The company's product lines include the Thoratec(R) VAD (VentricularAssist Device) and HeartMate LVAS with more than 12,000 devices implanted inpatients suffering from heart failure. Additionally, its InternationalTechnidyne Corporation (ITC) division supplies point-of-care blood testing andskin incision products. Thoratec is headquartered in Pleasanton, California.For more information, visit the company's web sites at http://www.thoratec.comor http://www.itcmed.com.

Thoratec, the Thoratec logo, HeartMate and HeartMate II are registeredtrademarks of Thoratec Corporation. ITC, is a registered trademark ofInternational Technidyne Corporation.

Many of the preceding paragraphs, particularly but not exclusively thoseaddressing future performance or timelines and milestones for clinical trials,contain forward-looking statements within the meaning of the Section 27A ofthe Securities Act of 1933 and Section 21E of the Securities Exchange Act of1934. These statements can be identified by the words, "believes," "views,""expects," "plans," "could," "will," and other similar words. Actual results,events or performance could differ materially from these forward-lookingstatements based on a variety of factors, many of which are beyond Thoratec'scontrol. Therefore, readers are cautioned not to put undue reliance on thesestatements. Investors are cautioned that all such statements involve risks anduncertainties, including risks related to the development of new marketsincluding Destination Therapy, the growth of existing markets for ourproducts, customer and physician acceptance of Thoratec products, changes inthe mix of existing markets for our products and related gross margin for suchproduct sales, the results of enrollment in and timing of clinical trials,including the HeartMate II, the effects of FDA regulatory requirements, theeffects of healthcare reimbursement and coverage policies, the effects ofprice competition from any Thoratec competitors and the effects of any mergerand acquisition related activities. Forward-looking statements contained inthis press release should be considered in light of these factors and thosefactors discussed from time to time in Thoratec's public reports filed withthe Securities and Exchange Commission, such as those discussed under theheading "Risk Factors," in Thoratec's most recent annual report on Form 10-K,and as may be updated in subsequent SEC filings. These forward-lookingstatements speak only as of the date hereof. Thoratec undertakes no obligationto publicly release the results of any revisions to these forward-lookingstatements that may be made to reflect events or circumstances after the datehereof, or to reflect the occurrence of unanticipated events.

SOURCE Thoratec Corporation