Add to balance / Manage account | User: | Log out |
Prospect News home > News index > List of issuers T > Headlines for Thoratec Corp. > News item |
Thoratec to add 90 patients in HeartMate trial
By Elaine Rigoli
Tampa, Fla., May 16 - Thoratec Corp. said the Food and Drug Administration has approved an Investigational Device Exemption supplement that allows enrollment of up to an additional 90 patients in the bridge-to-transplantation arm of the company's HeartMate 2 phase 2 trial under a continued-access protocol.
The HeartMate 2 is a continuous flow device designed to provide long-term cardiac support for advanced-stage heart-failure patients.
The original trial design for the bridge-to-transplantation arm called for enrollment of 133 patients. As of April 26, the company reported that 115 patients had been enrolled in the bridge-to-transplantation arm of the study.
Based in Pleasanton, Calif., Thoratec develops products to treat cardiovascular disease.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.