Israeli Heart Failure Treatment Secures FDA Breakthrough Status

An Israeli treatment for congestive heart failure has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).

The FDA awards Breakthrough Device designation to new types of therapeutic devices that present a reasonable expectation to “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.”

The ContraBand, developed by Or Yehuda-based Restore Medical, is designed to treat heart failure with reduced ejection fraction (HFrEF), which occurs when the left ventricle does not pump blood as well as it should.

The minimally invasive treatment is an implant put in place through a catheter that uses the right ventricle to support the left ventricle as it pumps blood.

The device aims to boost the functioning of the heart and improve quality of life in patients with left ventricle failure who previously had limited options for treatment.

According to Restore Medical, the FDA decision to grant Breakthrough Device Designation was based on compelling results from an ongoing feasibility study demonstrating promising outcomes in safety and efficacy.

The company has received funding from Israeli VC firm Peregrine Ventures, the European Innovation Council and an unnamed strategic investor.

July 24, 2024