HeartMate 3™ CE Mark Trial Meets Primary Endpoint

Highlights include the best six month survival documented in a LVAD CE Mark clinical study and low rates of adverse events with zero pump thrombosis events

PLEASANTON, Calif., Thoratec Corporation, a world leader in mechanical circulatory support therapies to save, support and restore failing hearts, today announced results from the HeartMate 3™ CE Mark trial.  HeartMate 3 met the primary endpoint, a comparison of six month survival to a performance goal derived from the INTERMACS registry, with six month survival of 92% surpassing the performance goal and representing the highest six month survival reported in a LVAD CE Mark clinical trial.  Results of the HeartMate 3 CE Mark trial were presented today during the 19^th Annual Scientific Meeting of the Heart Failure Society of America (HFSA 2015) in Washington, DC. 

"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," said Dr. Ivan Netuka, presenter of the HeartMate 3 CE Mark study data at HFSA and Deputy Head at the Institute for Clinical and Experimental Medicine (IKEM) in Prague, Czech Republic.  "HeartMate 3 is a very promising LVAD technology based on the advancement in clinical outcomes demonstrated in this trial," added Dr. Netuka.

Survival with HeartMate 3 at six months was 92% compared with the HeartMate II^® INTERMACS derived performance goal of 88%, achieving the primary endpoint and representing exceptional six month survival.  Overall functional status improved significantly with HeartMate 3 support as measured by changes in the six minute walk distance and NYHA classification.  At six months, patients experienced median improvement of 231 meters in the six minute walk test, and 83% of patients improved to NYHA Class I or II status, representing statistically significant improvements compared with baseline status. 

Overall adverse event rates with HeartMate 3 were either lower than or consistent with expectations for severely ill complex patients requiring LVAD support.  There were no instances of pump thrombosis, hemolysis, or device malfunction during the six month follow-up period.  Gastrointestinal bleeding, another common adverse event with LVAD therapy, occurred in only 8% of patients with HeartMate 3 and was notably below event rates in previously published data from prior LVAD clinical trials.  Stroke occurred in 12% of patients, including 8% with ischemic and 4% with hemorrhagic events.  Half of these events (3 of 6), were determined to be procedural related and may not represent risk related to the device.  Two of the three non-procedural related stroke events were Modified Rankin Scale (MRS) 1 in patients that remain on HeartMate 3 support.  Despite inclusion of these potentially non-device related and MRS 1 events, reported stroke rates in the CE Mark trial were still consistent with expected rates based on prior LVAD trial experience.

"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," saidD. Keith Grossman, President & Chief Executive Officer.  "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," he added.

HeartMate 3 is a centrifugal-flow chronic left ventricular assist system utilizing Full MagLev™, a fully magnetically levitated technology foundation designed to lower adverse event rates while also enhancing the ease of surgical placement through a compact size. 

The HeartMate 3 CE Mark trial is a prospective, multi-center, non-randomized study designed to examine the first human experience with HeartMate 3.  The study enrolled 50 patients at ten hospitals in six countries outside of the U.S. between June and November 2014.  Enrollment included 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 registry has been met.  Patient follow-up will continue during the first two years of ongoing support, while enrollment in the HeartMate 3 U.S. IDE trial remains ongoing.  Thoratec expects to receive CE Mark approval for HeartMate 3 during the fourth quarter of 2015.

Source:  Thoratec Corporation