HeartMate 3 Left Ventricle Assist Device meets primary endpoint in CE mark trial for heart failure- Thoratec Corp

Thoratec Corporation announced results from the HeartMate 3 CE Mark trial in patients with heart failure. HeartMate 3 Left Ventricle Assist Device 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. 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. Results were presented during the 19th Annual Scientific Meeting of the Heart Failure Society of America.