Thoratec's HeartMate II Scores High in ENDURANCE Trial - Analyst Blog

Thoratec Corp. THOR recently presented positive data for its HeartMate II heart pump device from the ENDURANCE destination therapy trial at the 35th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT 2015).

ENDURANCE is a randomized trial that was conducted at various sites in the U.S. enrolling 150 HeartMate II patients between Aug 2010 and May 2012, in order to evaluate the effectiveness of LVAD (Left Ventricular Assist Device) devices.

The data obtained from the ENDURANCE trial confirms the effectiveness of Thoratec’s Heartmate II for patients suffering from advanced heart failure disease, who are not fit for a heart transplant. The survival rate for two years stood at 68%. The data also affirmed the fact that patients implanted with Heartmate II have lower chances of adverse events like infection, sepsis and right heart failure.

Research also reveals one-year results from the ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) study.

This study was aimed at assessing the effects of HeartMate II LVAD compared with optimal medically managed patients. One year survival rate was found to be 80% in the HeartMate II group, as compared with 64% for medically managed patients.

The data gathered from the ROADMAP study showed that 39% of patients using HeartMate II were able to increase their walking distance by 75 meters in a six minute walk test, compared with 21% of patients in the optimal medical management group.

We feel these results in favor of Thoratec’s flagship HeartMate II will help increase the visibility and adoption rate of the device, going forward. This, in turn, should help Thoratec generate significant top-line growth. Notably, in the last reported quarter, the company sold 1034 HeartMate pumps worldwide, highlighting an increase of 6% on a year-over-year basis.

Earlier this month, Thoratec also received the final approval from the FDA to ramp up enrollment for its HeartMate III U.S. IDE clinical trial, which was initiated in September last year. With this approval, Thoratec can now extend the trial at up to 60 sites across the U.S. from the initial limited enrollment phase at 5 sites.

Notably, Thoratec completed enrollment of the HeartMate III CE Mark study in late 2014 and expects a commercial approval and a subsequent launch in the European markets by late 2015. We believe that positive clinical data from the HeartMate II and HeartMate III studies coupled with the eventual European launch of HeartMate III are likely to drive growth at Thoratec.

Zacks Rank

Currently, Thoratec has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical sector are LeMaitre Vascular LMAT, SurModics SRDX and Capricor Therapeutics CAPR. While LeMaitre Vascular and SurModics sport a Zacks Rank #1 (Strong Buy), Capricor Therapeutics holds a Zacks Rank #2 (Buy).


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