Thoratec (NSDQ:THOR) this morning defended the company’s HeartMate II left ventricular assist device, saying that a negative article published late last year in the New England Journal of Medicine hardly captured the full picture.
The NEJM article reported a sharp increase in rates of blood clots in patients implanted with the HeartMate II, using data from 3 centers that implanted more than 830 of the devices from January 2004 through May 2013.
"That only captures data from 3 centers," Thoratec president & CEO Gary Burbach told an audience at this week’s J.P. Morgan Healthcare conference in San Francisco. "This is a complex, multi-factorial issue involving a variety of factors including patient selection, patient management, pump implantation and we do see, given those various factors, that individual center experience varies greatly."
The California company is "actively in dialogue" with centers using the HeartMate II device, working out best practices for implantation, anticoagulation and other factors that may affect thrombosis rates. Other factors are looking better as well, with adverse events on the decline in recent years.
"The broader context is that survival has actually improved since the clinical trial, quite significantly here in the commercial experience," Burbach said. "We’ve also seen significant improvements in other areas – adverse events, stroke, bleeding and infection, in particular."
Thoratec was under pressure last month after the a team of researchers reported in the New England Journal of Medicine that they found a total of 72 confirmed cases of pump thrombosis in 66 patients and another 36 cases of suspected pump thrombosis. The study also found that blood clots were forming earlier following initial implantation, from 18.6 months to just 2.7 months.
The news sent THOR shares down 6.5% in a single day, with rival HeartWare International (NSDQ:HTWR) gaining on the news. HeartWare is no stranger to the blood clot issue; 2 years ago its share price suffered after clinical trial results of its HVAD pump showed thrombosis rates that were much higher than expected.
Thoratec got a Wall Street bump today following Burbach’s presentation, with shares up 1.2% to $37.81 as of about 12:10 p.m. EST. THOR shares have gained 3% since the start of the year.