Thoratec has received approval to CE-mark its HeartMate II LVAS (left ventricular assist system), allowing the commercial launch of the device in Europe. The HeartMate II is a next-generation cardiac assist device designed to provide long-term support for patients in advanced-stage heart failure. The HeartMate II is currently undergoing a Phase II pivotal clinical trial in the US for both destination therapy and bridge-to-transplantation.
The HeartMate II is a continuous flow device designed to provide long-term cardiac support for patients who are in advanced-stage heart failure. It is an implantable LVAS powered by a rotary pumping mechanism, approximately a fifth of the size of the company's current FDA-approved HeartMate XVE device. The HeartMate II is designed to have a much longer functional life than currently approved pulsatile devices and to operate more simply and quietly. The device provides bloodflow through the circulatory system on a continuous basis with only one moving part. It is also smaller and easier to implant than pulsatile devices.
The regulatory application for European approval was based on data from the first 20 patients implanted in the company's Phase I US trial and in a European study. Patients enrolled in the entire pilot study population accounted for more than 7,900 days of cumulative support, with each supported from between one day and 717 days.
As of October 2005, a total of 153 patients have been enrolled in the worldwide HeartMate II trial, including 102 patients in the company's Phase II US pivotal trial. This includes 52 in the bridge-to-transplantation arm and 50 in the destination therapy arm. Excluding control-arm patients, 143 patients have now been implanted with the HeartMate II. Having both bridge-to-transplantation and destination therapy arms make this the first time that the FDA has approved a clinical trial with both indications in one protocol. The bridge-to-transplantation arm will involve 133 patients in total, with the primary endpoint being the rate of survival to transplantation, or 180 days. The destination therapy arm of the study will involve 200 total patients, randomised to either the HeartMate II or HeartMate XVE on a 2:1 basis respectively. The study provides for a composite two-year endpoint, which includes patient survival, rate of neurological events and device reliability.
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