The original trial design for the BTT arm called for enrollment...

The original trial design for the BTT arm called for enrollment of 133 patients. As of April 27, 2007, the company reported that it had enrolled 296 patients in the BTT arm of the study. The original DT trial design called for enrollment of 200 randomized patients. As of April 27, 2007, 188 patients had been enrolled in the randomized arm of the trial.

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) Amendment seeking FDA approval of the HeartMate II for the BTT indication.