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.
A quick refresher about the company’s technology:
At the core of the HeartWare platform is the proprietary use of a “hybrid” system for suspending the impeller (or rotor), the only moving part within the pump. The impeller is suspended using a combination of passive magnets and a hydrodynamic thrust bearing. The hydrodynamic thrust bearing works by establishing a “cushion” of blood between the impeller and the pump housing. Once power is applied to the device and the impeller begins to rotate, there are no points of mechanical contact within the pump, effectively ensuring a “wearless” system. The elimination of mechanical bearings is expected to lead both to longer term device reliability and to a reduced risk of physical damage to blood cells as they pass through the pump.
Press release: HeartWare Receives Second Patient Allotment Under Continued Access Protocol for Pivotal U.S. Bridge-To-Transplant Clinical Trial …
Product page: HeartWare Left Ventricular Assist Devices …
Flashbacks: Medical Heart Pumps from HeartWare: HVAD, MVAD and PedVAD; HeartWare Heart Pump Shows Positive Results in Clinical Study;
(hat tip: MassDevice)