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.
According to the company’s website, the innovative, reversible therapy leverages the right ventricle to support the left ventricle. It improves left ventricle ejection fraction and restores optimal ventricular geometry. Restore Medical says no approved treatments currently exist on the market for this condition, meaning ContraBand could “transform the way congestive heart failure patients are treated.”
Restore Medical said the FDA granted the breakthrough nod based on results from an ongoing feasibility study. The study already demonstrated promising outcomes in safety and efficacy, according to a news release.
Results included significant left ventricular volume reduction and improved hemodynamic function. Restore Medical also reported enhanced physical capacity in patients treated with the ContraBand device.
