Thoratec submits amended HeartMate PMA:
This article was originally published in Clinica
Thoratec has filed an amendment to the PMA seeking approval of its HeartMate II LVAS (left ventricular assist system) for bridge-to-transplantation (BTT). The Pleasanton, California firm submitted the original regulatory application in December 2006. The updated filing contains data from 279 further patients and is intended to address safety and efficacy queries raised by the US FDA. The company also completed enrolment of 200 patients in the destination therapy (DT) arm of its HeartMate II trial, which will be used to seek approval for long-term use of the device. Thoratec received clearance to enrol an additional 60 patients in both the DT and BTT arms.