Restore Medical’s ContraBand to Treat Heart Failure Nabs FDA Breakthrough Nod

Restore Medical has secured breakthrough device status from the U.S. Food and Drug Administration for its ContraBand device to treat heart failure (HF) with reduced ejection fraction (HFrEF) with specific criteria.

The designation specifically covers HFrEF patients who retain symptoms in spite of maximally tolerated, guideline-directed medical therapy, who also suffer from pulmonary hypertension or right heart failure.

ContraBand holds the title of the world’s first transcatheter pulmonary artery banding (PAD) system made specifically for HFrEF patients to improve their quality of life. The minimally invasive procedure addresses the unmet need for patients with left ventricle failure with limited treatment options, Restore said.

The catheter-delivered implant leverages the right ventricle to support the left ventricle, improving ejection fraction and restoring optimal ventricular geometry.

The breakthrough designation was based on results from the company’s ongoing feasibility study that showed promising outcomes for ContraBand’s safety and efficacy. These include significantly lowered ventricular volume, better hemodynamic function, and improved physical capacity.

Restore Medical was founded by Stephen Bellomo, who serves as CTO, Dr. Elchanan Bruckheimer, who serves as Medical Director, and Aaron Feldman. The company is led by CEO Gilad Marom.

Restore Medical is funded by Peregrine Ventures, the European Innovation Council (EIC), and an undisclosed strategic investor,