Home » Terumo Heart Submits IDE for Ventricular Assist System
Terumo Heart Submits IDE for Ventricular Assist System
Terumo Heart has submitted an investigational
device exemption (IDE) for its DuraHeart left-ventricular assist system to the FDA as a first step in getting approval for a trial to test the device long-term
in patients ineligible for a heart transplant, the company says. Terumo is enrolling patients for the device’s Bridge-to-Transplant trial, it says.
DuraHeart already has a CE Mark and is available in Europe.
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