'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.
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,' said
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.
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The preceding paragraphs contain forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, 'believes,' 'expects,' 'should,' 'could,' 'will,' and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond
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SOURCE
Neil Meyer, Senior Director of Finance and Investor Relations, Thoratec Corporation, (925) 738-0029
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