Thoratec Corp (THOR) recently completed enrollment of 50 patients under the HeartMate III CE Mark trial at ten sites across Europe, Canada and Australia. The trial will monitor these patients over the next six months (til May 2015). The company expects to submit the clinical data once this process is complete.
HeartMate III is a next-generation continuous flow left ventricular assist device (LVAD) based on fully magnetically levitated technology. This technology helps in reducing adverse event rates through improved hemocompatibility while its compact size allows easy surgical placement.
Thoratec’s previous generation HeartMate II is an intermediate-to-chronic LVAD designed for the treatment of advanced heart failure. Notably, HeartMate II has been approved for use in North America and the EU.
In September this year, Thoratec stated that it has begun enrolling patients for the U.S. trial, with the first implant of HeartMate III heart pump carried out by Dr. James Long of the INTEGRIS Baptist Medical Center, Oklahoma.
Patient enrollment under the trial, which began in a safety phase under conditional approval from the U.S. Food and Drug Administration (FDA) at five sites, is expected to cover up to sixty sites following full approval from the FDA.
With further enrollment, Thoratec expects to evaluate the safety and efficacy of the HeartMate III technology to advance the treatment of heart failure and improve quality of life through chronic circulatory support.
However, even as the company is making significant clinical progress with its pipeline products, HeartMate III and HeartMate PHP, sales of the flagship HeartMate II failed to impress in the last reported quarter.
HeartMate product revenues plunged a considerable 18.8% year over year to $91.6 million, as shipments of HeartMate pumps fell 14% in the third quarter of 2014. Sluggish international sales, particularly in Japan, were a major disappointment. The company also failed to sell any HeartMate II unit in the country during the quarter.
Thoratec slashed its adjusted earnings and revenue guidance owing to dampened expectations from the HeartMate II product line on the back of near-term challenges. Also, the company anticipates higher operating expenses in the fourth quarter of 2014 owing to accelerated clinical trial activity, targeted commercial investments, and spiraling product development project expenses.
2015 is viewed to be a transition year for Thoratec as it seeks to reaccelerate market growth. In such a scenario, the completion of enrollment activity is a positive for the company. Thoractec expects to launch HeartMate III commercially in countries under CE Mark approval in late 2015.
Zacks Rank
Currently, Thoratec has a Zacks Rank #4 (Sell). Better-ranked stocks include AngioDynamics (ANGO), Edwards Lifesciences Corp. (EW) and Fluidigm Corp (FLDM). While AngioDynamics sports a Zacks Rank #1 (Strong Buy), Edwards Lifesciences and Fluidigm hold a Zacks Rank #2 (Buy).
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