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HeartWare: MVAD CE Mark Trial May Be Further Delayed

Left ventricular assist device maker HeartWare announces it is investigating adverse events in some patients implanted with the next-gen MVAD during the CE Mark trial.

Just a day after competitor St. Jude Medical announced CE Mark approval for its next-generation HeartMate 3 left ventricular assist system (LVAS), HeartWare has announced it may not be restarting its CE Mark trial for the MVAD in November, as previously communicated.

In early September, HeartWare announced that patient enrollment in the CE Mark trial for its MVAD device would be paused to allow for a minor fix of a circuit board in the device's external controller. At the time, 11 patients had been implanted and CEO Doug Godshall said that he expected the trial to be able to resume in November. He also said that the company was happy with the MVAD's clinical performance thus far.

In an October 13 SEC 8-K filing, HeartWare noted that after the decision to pause the clinical trial, the company then began looking into certain reported adverse events that they emphasize are similar to events seen in prior ventricular assist device (VAD) trials. In addition, HeartWare points out that the company also investigated adverse events during its 2007 CE Mark trial for its now-commercial HVAD device. According to the filing, patient implants for the CE Mark trial may not resume in November, but the company continues to support the MVAD System and design. HeartWare's executives are expected to give more details on the company's October 29 earnings call.

A HeartWare spokesperson did not return a request for comment on Tuesday. Here is an excerpt from the company's 8-K statement:

Subsequent to that action and following discussions with the Company's trial investigators, HeartWare began investigating causes of reported adverse events in certain clinical trial patients. The events being analyzed are typical of those seen in other clinical trials for ventricular assist devices. HeartWare took similar actions successfully during its initial human study for the HVAD system during the HVAD CE Mark clinical trial in 2007. 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. HeartWare intends to provide additional commentary related to the MVAD clinical trial on its third quarter financial results call and webcast scheduled for October 29, 2015. It has been, and remains, the intention of the Company to present and publish clinical data following the completion of enrollment and follow-up for all trial patients."

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  • 500 Old Connecticut Path, Framingham, MA 01701, United States
  • HeartWare