Thoratec (NSDQ:THOR) said today the CE Mark trial of its HeartMate 3 left ventricular assist device has met its primary endpoint and reported a 92% rate of survival at 6 months. Data from the trial was presented at the Heart Failure Society of America’s annual meeting in Washington D.C.
The HeartMate 3 is a centrifugal-flow chronic left ventricular assist system which uses magnetically levitated technology and a reduced size for easier placement, the Pleasanton, Calif.-company said.
“The CE Mark trial data represents a very positive initial experience with HeartMate 3, including high survival rates, material improvement in functional status, and very low adverse event rates highlighted by zero pump thrombosis events. HeartMate 3 is a very promising LVAD technology based on the advancement in clinical outcomes demonstrated in this trial,” Dr. Ivan Netuka of Prague’s Institute for Clinical and Experimental Medicine said in prepared remarks.
The 50-patient prospective, multi-center, non-randomized study reported a 92% survival rate compared to the company’s HeartMate II INTERMACS registry derived goal of 88%. The study reported improvement on 6-minute walks and NYHA classification, with HeartMate 3 patients walking 231 meters more in the walk test and 83% improving to NYHA class I or II status.
“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,” CEO D. Keith Grossman said in a press release.
The study reported adverse event rates lower or consistent with expectations, the company said. Gastrointestinal bleeding occurred in 8% of patients, ischemic stroke in 8% and hemorrhagic stroke in 4%. Thoratec said half of the events were determined to be ” procedural related and may not represent risk related to the device.”
Thoratec said it expects to receive CE Mark approval in the European Union during the 4th quarter of 2015.
Earlier this month, Thoratec issued a warning to users of its HeartMate II left ventricular assist system over battery expiration dates in its pocket system controller, which the company specified does not affect normal heart pump function.