EU approval HeartMate 11

Next-Generation Cardiac Assist Device (HeartMate II) for Long-term Cardiac Support in EU
On Nov. 7, the European Commission approved a next-generation left ventricular assist system (LVAS; HeartMate II, made by Thoratec Corporation) to provide long-term support for patients in advanced-stage heart failure.
The continuous-flow implantable device is approximately one fifth the size of the company's HeartMate XVE product (which is approved for use in the United States) and may be used in a broader range of body sizes.
It is designed to have a much longer functional life and operate more quietly compared with currently approved pulsatile devices.
The approval was based on data from the first 20 patients implanted with the device in a European study and a US phase 1 clinical trial (HeartMate II Axial Flow LVAS: Suitability for Advanced Congestive Heart Failure). The data reflected more than 7,900 days of cumulative support with individual use ranging from 1 to 717 days.
Results from the phase 1 trial in 34 patients (median support, 160 days; range, 6 - 562 days) showed that 43% of 14 patients supported by the device for 3 months or longer improved by 3 New York Heart Association functional classes. In addition, 75% of patients demonstrated improved exercise capacity compared with baseline, as evaluated by increases in walking distance.
No device-related deaths or pump failures were reported, and 2 pump-related infections occurred.
According to a company news release, the device's potential for restoring hemodynamic function may render it suitable for use in a wider range of advanced-stage heart failure patients to significantly improve their survival and quality of life.
The device is currently undergoing a pivotal clinical trial in the United States for both destination therapy (DT) and bridge-to-transplantation (BTT) indications. Thus far, 102 patients have been enrolled in the study. The DT group (n = 50) will be evaluated on survival, rate of neurologic events, and device reliability in a 2-year composite end point; the primary end point of the BTT group (n = 52) will be rate of survival to transplantation.
source: medscape


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