cap

Info from SS and followed the lead – VCR should be able to apply for CAP to continue on with implants between completion of current trials until FDA approval.


Continued Access Protocol


http://phx.corporate-ir.net/phoenix.zhtml?c=95989&p=irol-newsArticle&ID=857141&highlight=

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Thoratec Receives FDA Approval of Continued Access Protocol for Bridge Arm of Its HeartMate(R) II Pivotal Trial
Approval Allows for Enrollment of up to an Additional 90 Patients
PLEASANTON, Calif., May 16 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, today said that the FDA has approved an IDE (Investigational Device Exemption) supplement that allows enrollment of up to an additional 90 patients in the Bridge-to-Transplantation (BTT) arm of the company's HeartMate II Phase II trial under a Continued Access Protocol (CAP).
The original trial design for the BTT arm called for enrollment of 133 patients. As of April 26, 2006, the company reported that 115 patients had been enrolled in the BTT arm of the study. Patient enrollment under the CAP can begin at the 40 centers participating in the trial once the initial 133 patients are enrolled, subject to IRB approvals at the centers. The CAP patients will be enrolled and followed under the original protocol of the pivotal trial. The addition of these patients will not impact the timing for the company's planned submission of a PMA (PreMarket Approval) Supplement seeking FDA approval of the HeartMate II for the BTT indication……….


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