The approval follows a successful clinical trial involving more than 450 bridge-to-transplantation (BTT) patients, including those enrolled under continued access protocols, and a unanimous recommendation for approval from the FDA Circulatory System Devices Advisory Panel in November, 2007.
The approval allows the HeartMate II to be used to treat small patients (BSA < 1.5) based on body habitus if the treating clinician believes that the patient could benefit from the device. In addition, Thoratec will conduct a post-market study that includes a concurrent comparator. The study will follow 169 HeartMate II patients until outcome, or one year - whichever comes first - and gather data regarding survival, adverse events, patient gender, small patients and anticoagulation levels. Gary Burbach, president and CEO of Thoratec, said: "The HeartMate II is the first continuous flow device to receive FDA approval for this intended use in the US, representing a milestone in the treatment of advanced-stage heart failure patients and for the clinicians who treat them."