Thoratec has revealed the results from prospective, multi-center and non-randomized trial of HeartMate 3 centrifugal-flow chronic left ventricular assist system.
According to the firm, the trial reached the primary endpoint, a comparison of six-month survival to a performance goal derived from the Intermacs registry, with six-month survival of 92%, exceeding the highest six-month survival reported in a LVAD CE mark clinical trial.
Thoratec president and CEO Keith Grossman said: "We are extraordinarily pleased with the performance of HeartMate 3 in this initial experience, and it is gratifying to see the promise of our Full Maglev technology demonstrated clearly in these clinical results.
"We look forward to working with clinicians, both in ongoing clinical trials and in the imminent commercial launch in Europe, to extend the benefits of this exciting new technology to the underserved and growing population of advanced heart failure patients."
HeartMate 3 uses Full MagLev, a fully magnetically levitated technology foundation designed to lower adverse event rates, while also increasing the ease of surgical placement through a compact size.
In the trial, the company enrolled 50 patients at ten hospitals in six countries outside of the US between June and November 2014.
Enrollment comprised of both bridge-to-transplant and destination therapy patients in NYHA Class IIIb or IV heart failure, and the primary endpoint comparing six month survival to a performance goal derived from the Intermacs has been reached.
During the first two years of ongoing support, patient follow-up will continue and enrollment in the HeartMate 3 US IDE trial remains ongoing.
The company is expecting to secure CE mark approval for HeartMate 3 during the fourth quarter of this year.