Restore Medical, a pioneering medical device company in the field of interventional cardiology, is proud to announce that it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its ContraBand™ device. This designation is specifically for treatment of heart failure with reduced ejection fraction (HFrEF) patients who remain symptomatic despite maximally tolerated guideline-directed medical therapy, without significant pulmonary hypertension or right heart failure.
FDA’s Breakthrough Device Designation program is intended to expedite the development and review of medical devices that offer significant advantages over existing treatments for serious or life-threatening conditions. This designation marks a significant milestone in the company’s mission towards improvement of cardiac care for heart failure patients as it highlights the potential of the ContraBand™ device to address critical unmet needs in the treatment of HFrEF patients.
ContraBand™ is the world’s first transcatheter Pulmonary Artery Banding (PAB) system designed specifically for HFrEF patients with the aim of improving the quality of life for these patients. This minimally invasive procedure offers hope to patients suffering from left ventricle failure who currently have limited treatment options. FDA’s decision to grant Breakthrough Device Designation was based on compelling results from an ongoing feasibility study demonstrating promising outcomes in safety and efficacy. These results include significant left ventricular volume reduction, improved hemodynamic function, and enhanced physical capacity in patients treated with the ContraBand™ device.
