FDA Grants Breakthrough Device Status to New Heart Implant

Restore Medical, an Israeli healthcare technology company focused on developing therapies for heart failure, has received breakthrough device designation from the FDA for its new ContraBand device. The designation specifically covers patients with heart failure with reduced ejection fraction (HFrEF) with symptoms that persist even after receiving guideline-based medical therapy (GDMT). Patients must present without significant pulmonary hypertension or right ventricular failure to be considered for treatment.

ContraBand is a transcatheter pulmonary artery banding system designed to improve the quality of life of patients with chronic HFrEF. It is implanted using a minimally invasive procedure that uses the patient’s right ventricle to support the left ventricle.

The FDA’s decision was based in part on six-month and one-year results from a clinical trial investigating the potential safety and effectiveness of the ContraBand device. In March, Restore Medical released an update on the first-in-human study of 15 heart failure patients treated with the device. All of the participants were already on GDMT, and all of them experienced improvement in symptoms—including improved left ventricular ejection fraction—after treatment.