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| MVAD pump--Courtesy of HeartWare |
HeartWare ($HTWR) was down about 30% after announcing that it might not be able to resume a European trial of its MVAD implantable heart pump next month, a month after the company put the study on hold due to manufacturing and software issues with the device.
In July, the Framingham, MA-based company kicked off a CE mark trial of its next-generation MVAD blood pump for heart failure patients, planning to enroll 60 patients in 11 sites throughout Europe. But in September, HeartWare halted enrollment of the trial after it got reports of adverse events in certain trial subjects. The company did not offer many details about the events other than saying that they're "typical of those seen in other clinical trials for ventricular assist devices," HeartWare said at the time, as quoted by MassDevice.
But apparently, those problems have not yet been resolved and as a result, HeartWare is holding off on the trial. The news was enough to send shares tumbling 12.1% to $44.03 at close yesterday, and down 20.4% to $35.04 in early trading today.
"Although HeartWare may not re-initiate enrollment in the MVAD clinical trial in November as it previously expected, HeartWare remains confident in its MVAD system and the potential for the MVAD design to meaningfully improve outcomes for ventricular assist patients," the company said in an SEC filing.
The news deals a blow to HeartWare, which is competing tooth and nail for its share of the market with rival Thoratec, which St. Jude Medical ($STJ) purchased over the summer. St. Jude's HeartMate III Left Ventricular device recently snagged a CE mark, moving the company one step ahead in the devicemakers' battle for dominance. And some analysts are predicting that St. Jude will ultimately emerge the winner, with FDA approval for its product on track for 2018.
Meanwhile, HeartWare is working hard to expand its device's reach, touting its small size and ease of use as potential advantages over current technology. The company has already submitted an Investigational Device Exemption submission to the FDA, which would allow MVAD to be use in U.S. clinical trials. And Health Canada is also reviewing the company's submission for a 15-patient, three-center study that would start later this year, adding fuel to HeartWare's regulatory fire.
- here's HeartWare's SEC filing
- read the MassDevice story
- get St. Jude's statement
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