Thoratec's HeartMate III CE Mark Trial Results Positive
Thoratec Corp THOR recently announced that the HeartMate III CE mark trial has successfully met its primary endpoint. HeartMate III is a next-generation continuous-flow left ventricular assist device (LVAD) based fully on magnetically levitated technology.
Trial results showed that at the end of six months, 92% of the patients using HeartMate III survived as compared with HeartMate II INTERMACS' benchmark of 88% (primary endpoint). Moreover, patients experienced functional improvement and at the same time adverse event rates were much lower or consistent with trial expectations.
Thoratec announced the results at the 19th Annual Scientific Meeting of the Heart Failure Society of America (HFSA 2015). The trial enrolled 50 patients, at 10 hospitals across 6 countries, by the end of 2014. Enrollment included both bridge-to-transplant and destination therapy patients in NYHA Class IIIb or IV heart failure.
Thoratec now seeks to attain the CE mark approval in the fourth quarter of 2015.
Meanwhile, in April, the company received the final approval from the FDA to broaden enrollment under its HeartMate III U.S. IDE clinical trial, which commenced in Sep 2014. This approval allows Thoratec to extend the trial at up to 60 sites across the U.S. from the initial limited enrollment phase at 5 sites.
We believe that positive clinical data from the HeartMate III study and the subsequent European launch should help drive the company's growth. However, accelerated clinical trial activity, targeted commercial investments and product development costs will likely increase the operating expenses. We believe this may impede the company's bottom line in the near term.
In July, Thoratec agreed to be acquired by medical device maker St. Jude Medical STJ for $3.4 billion. The deal is expected to be completed in the fourth quarter of 2015. Thoratec, an established player in the global Ventricular Assist Device (VAD) space, holds approximately 60% share, which we believe will substantially help St. Jude gain market traction.
Zacks Rank & Key Picks
Currently, Thoratec sports a Zacks Rank #1 (Strong Buy).