HeartWare wins FDA nods for clinical trials

September 7, 2010 by MassDevice staff

The Food & Drug Administration grants HeartWare International Inc. an investigational device exemption supplement to add more patients to its Advance bridge-to-transplant trial and cleared the way for full enrollment in the Endurance destination therapy trial.

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HeartWare International Inc. (NSDQ:HTWR) won a pair of approvals from the Food & Drug Administration for clinical trials of its cardiac assist device.

The Framingham, Mass.-based medical device maker said the FDA granted an investigational device exemption supplement for its Advance bridge-to transplant trial for an additional 54 patients.

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