The mood was pretty somber going into Heartware’s (Framingham, Mass.) breakout session during the 34th annual J.P.Morgan Healthcare conference. But why wouldn’t it be? It’s not everyday that a med-tech CEO has to discuss halting a European trial on one of its most promising technologies.
But that’s exactly what Doug Godshall, Heartware president/CEO did. Godshall, who took the leadership position of Heartware in 2006, delivered the bad news across a sea of somewhat disenchanted faces during the conference. He did a great job, but honestly, is there ever a “good way” to deliver bad news?
You see, Godshall revealed there were thrombus complications with MVAD that occurred in late December, causing the company to once again pause its CE-mark trial. Heartware's MVAD pump is a continuous axial flow pump. The MVAD trial is a prospective, non-randomized, single-arm study, that began in July. The trial will be implant patients with the MVAD pump via sternotomy or thoracotomy, with a primary endpoint of survival at six months. The thrombus complications that occurred during the trial are from sustained suction that stem from Qpulse, a software algorithm that periodically regulates the speed of MVAD to promote aortic valve opening during left ventricular support.
And it should be pointed out that those December complications – well they come on the heels of Heartware pausing the MVAD trial back in September. The study was initially paused to allow for a minor circuit board fix for the device's external controller. Now the company is in the process of exploring a few options. It can tinker with the algorithm; or it can do a redesign of the MVAD. There is no real concrete timetable for this but Godshall said it would take a minimum of 18 months to get back into the clinic if a design change was needed for the device.
What makes this pill even harder to swallow is that it’s chief rival in the space, Thoratec Corp. (Pleasanton, Calif.) is being integrated quite nicely after it was acquired by St. Jude Medical Inc. (Rochester, Minn.) for $3.4 billion. During St. Jude’s presentation at J.P. Morgan, it’s CEO Michael Rousseau spoke up about the Thoratec acquisition and spoke about its reasons to go for Thoratec.
"We saw a technology and we liked it," Rosseau said of Thoratec’s Heartmate. "We thought Heartmate data looked really good. "We thought there were a lot of questions marks in Heartware’s [data]. We think the Thoratec acquisition was the right decision."
The only bright spot for Heartware is that it is on track in its bid to secure a destination therapy (DT) indication for the HVAD system based on positive trends observed in the ENDURANCE2 trial. Heartware said it could submit to the FDA for approval in mid-2016. That could be a tremendous boost to the company, and help offset some of the bad news surrounding the MVAD trial.