MedGadget -- HeartWare, an Australian and Framingham, Massachusetts developer of ventricular assist devices that utilize the company’s proprietary “wearless” impeller suspension system (see on right), has announced FDA approval to “enroll a second allotment of 54 patients in its ‘ADVANCE’ bridge-to-transplant clinical trial... The FDA granted an initial allotment of 54 patients in April 2010 and the final patient was implanted under the initial allotment in August 2010.” Given the news, the company is continuing its efforts to have its device FDA approved as a bridge to transplantation sometime in the (hopefully) not too distant future. HeartWare has already received CE Marking for the HeartWare System in the European Union.
