HeartWare's HVAD implant wins expanded European approval

We have good news to tell you regarding HeartWare International's ($HTWR) ventricular assist system. The Framingham, MA and Sydney-based company gained a CE mark addendum in Europe that will allow long-term use of the implant for all patients at risk of dying from refractory, end-stage heart failure. An expanded indication allows more patients to have a treatment option if they're not eligible for a heart transplant, company president and CEO Doug Godshall said in a statement. The company's device is considered to be precedent setting because it is implanted next to the heart and doesn't require abdominal surgery needed for competing products. It initially gained CE marking in 2009 as a bridge-to-transplant. In the U.S., the company is pursuing clinical studies to use the device as both a bridge-to-transplant and destination therapy, the latter of which is similar to the CE mark addendum. Release

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