Restore Medical’s ContraBand System Gains the US FDA’s Breakthrough Device Designation for Heart Failure with Reduced Ejection Fraction
Shots:
- The US FDA has granted BDD to the company’s ContraBand System for treating heart failure with reduced ejection fraction (HFrEF) in patients, symptomatic to optimal medical therapy, without significant pulmonary hypertension or right heart failure
- The designation was supported by an ongoing feasibility trial that showed a reduction in left ventricular volume with improvements in hemodynamic function & physical capacity
- ContraBand device is a minimally invasive transcatheter Pulmonary Artery Banding (PAB) system intended to improve quality of life in patients with left ventricle failure
Ref: PR Newswire | Image: Restore Medical
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
