(Adds details)
Dec 4 (Reuters) - Cardiac device maker Thoratec Corp said an interim analysis of a late-stage study showed its HeartMate II device to be statistically superior to an existing heart pump, sending its shares up 14 percent after the bell.
Thoratec said the study compared the company's device as a destination therapy -- treatment for patients who do not qualify for a transplant -- to its currently marketed heart pump called HeartMate XVE.
The HeartMate II cardiac device is intended for advanced-stage heart failure patients, and the company plans to file for a pre-market approval for its use as a destination therapy with the U.S. Food and Drug Administration in the first half of 2009.
Thoratec's shares, which closed at $24.75 Thursday on Nasdaq, were trading up about $3 at $27.54 after the bell.
(Reporting by Vidya L Nathan in Bangalore; Editing by Anil D'Silva) Keywords: THORATEC/ (vidya.loganathan@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: vidya.loganathan.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2008. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
Dec 4 (Reuters) - Cardiac device maker Thoratec Corp said an interim analysis of a late-stage study showed its HeartMate II device to be statistically superior to an existing heart pump, sending its shares up 14 percent after the bell.
Thoratec said the study compared the company's device as a destination therapy -- treatment for patients who do not qualify for a transplant -- to its currently marketed heart pump called HeartMate XVE.
The HeartMate II cardiac device is intended for advanced-stage heart failure patients, and the company plans to file for a pre-market approval for its use as a destination therapy with the U.S. Food and Drug Administration in the first half of 2009.
Thoratec's shares, which closed at $24.75 Thursday on Nasdaq, were trading up about $3 at $27.54 after the bell.
(Reporting by Vidya L Nathan in Bangalore; Editing by Anil D'Silva) Keywords: THORATEC/ (vidya.loganathan@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: vidya.loganathan.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2008. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.