Restore Medical wins FDA breakthrough nod for heart failure treatment device

Restore Medical announced today that it received FDA breakthrough device designation for its ContraBand heart failure treatment device.

Or-Yehuda, Israel-based Restore Medical designed its ContraBand device for the treatment of heart failure in reduced ejection fraction (HFrEF) patients who remain symptomatic despite maximally tolerated guideline-directed medical therapy, without significant pulmonary hypertension or right heart failure.

The transcatheter pulmonary artery banding (PAB) system aims to improve the quality of life in HFrEF patients. Its minimally invasive procedure offers an option for patients with left ventricle failure who currently have limited treatment possibilities.

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