Thoratec HeartMate II Problems Dismissed by Manufacturer

The head of Thoratec Corporation pushed back this week against recent research that suggests individuals who recently received the company’s HeartMate II left ventrical assist system (LVAS) may face an increased risk of blood clots.

In a study published in November 2013, doctors from the Cleveland Clinic highlighted a sharp uptick in the number of blood clot-related problems with the Thoratec HeartMate II since March 2011. The doctors warned that rates of clot formation rose nearly four times when compared to artificial heart pumps implanted before then.

At the J.P. Morgan Healthcare conference in San Francisco this week, Thoratec Chief Executive Officer and President Gary Burbach largely dismissed the findings, indicating that the study was highly limited and does not provide a complete picture of HeartMate II performance.

The Thoratec HeartMate II LVAS is a coronary implant given to patients whose hearts are too weak to efficiently pump blood. Former Vice President Dick Cheney is perhaps the most famous recipient, but they have been widely used among individuals with advanced heart disease who are waiting for a heart transplant or are too weak to undergo such a procedure.

After examining data from three different hospitals, researchers from Cleveland Clinic were able to identify that over the past few years there has been an increase in the rate of clot formation during the months after the HeartMate II was implanted, confirming what doctors at the hospital suspected based on their own experiences. The findings were published in the New England Journal of Medicine on November 27.

Following the study, Thoratec shares dropped in value from $43.3 per share to $35.54 per share at its lowest point on December 17, 2013. The stock has recovered little, with shares priced at $37.35 per share.

Burback said this week that the findings do not provide enough information to give a clear analysis of HeartMate II’s safety. He said data from just three clinics were not enough given the complexity of patient selection and management, pump implantation and other factors.

The statement comes just days after the Shareholders Foundation announced it was initiating an investigation of Thoratec on behalf of investors who lost money. According to a press release issued by the Shareholders Foundation, the group is looking at potential securities laws violations by Thoratec, concerning whether the company mislead investors regarding its business and operations based on the revelations over the HeartMate II.