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FDA grants new heart failure implant its breakthrough device ...

Restore Medical's ContraBand device, a transcatheter pulmonary artery banding system for HFrEF patients, received FDA breakthrough designation. It aims to improve life quality via a minimally invasive procedure, supported by positive clinical trial results showing symptom improvement in patients on GDMT.


Reference News

FDA grants new heart failure implant its breakthrough device ...

Restore Medical's ContraBand device, a transcatheter pulmonary artery banding system for HFrEF patients, received FDA breakthrough designation. It aims to improve life quality via a minimally invasive procedure, supported by positive clinical trial results showing symptom improvement in patients on GDMT.

Restore Medical wins FDA breakthrough nod for heart failure treatment device

Restore Medical's ContraBand device, designed for HFrEF patients, received FDA breakthrough designation. It offers a minimally invasive PAB system to improve life quality by leveraging the right ventricle to support the left, enhancing ejection fraction and ventricular geometry. Promising study results show significant volume reduction and improved function.

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