Restore Medical has announced that its ContraBand™ device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
The designation is aimed at treating patients with heart failure with reduced ejection fraction (HFrEF) who remain symptomatic despite receiving the highest level of guideline-directed medical therapy, without any significant pulmonary hypertension or right heart failure.
ContraBand™ is the world’s first transcatheter Pulmonary Artery Banding (PAB) system specifically developed for HFrEF patients, with the goal of enhancing their quality of life.
This breakthrough device Program is designed to accelerate the development and review of medical devices that offer substantial improvements over current treatments for serious or life-threatening conditions.
This designation represents an important step in efforts to advance cardiac care, highlighting the potential of the ContraBand™ device to address unmet needs in the treatment of HFrEF patients.
This minimally invasive procedure provides new hope for patients with left ventricular failure, offering an alternative for those who currently have few treatment options available.
This results gives positive outcomes in safety and efficacy and improved hemodynamic function, and elevated physical capacity in patients treated with the ContraBand™ device.
Source: https://www.prnewswire.com/news-releases/restore-medical-receives-breakthrough-device-designation-from-fda-for-contraband-system-to-treat-hfref-patients-302200547.html
