Restore Medical gets FDA breakthrough device status for ContraBand device in heart failure

Restore Medical, a leader in interventional cardiology innovations, has achieved a significant milestone with the U.S. Food and Drug Administration’s (FDA) Breakthrough Device Designation for its pioneering ContraBand device. This designation underscores the potential of ContraBand to transform the treatment landscape for patients suffering from heart failure with reduced ejection fraction (HFrEF), who have not responded adequately to existing therapies.

Breakthrough Device Designation: A Milestone for Cardiac Care

– Significance of Designation: The FDA’s Breakthrough Device Designation is reserved for medical devices that demonstrate potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. For Restore Medical, this recognition accelerates the review process for ContraBand, facilitating quicker access to a critical market.

– Device Overview: The ContraBand is the first transcatheter Pulmonary Artery Banding (PAB) system designed exclusively for HFrEF patients. It targets those without significant pulmonary hypertension or right heart failure, offering a new hope for improved quality of life through a minimally invasive procedure.

Restore Medical’s ContraBand, a breakthrough device, is setting new standards in treating heart failure with reduced ejection fraction.

Innovative Approach to Heart Failure

– Study Outcomes: The FDA’s decision was influenced by promising data from ongoing feasibility studies indicating that the ContraBand device can significantly reduce left ventricular volume, enhance hemodynamic function, and boost physical capacity in patients.

– Procedure and Benefits: By adjusting the pulmonary artery’s diameter, ContraBand effectively alleviates stress on the left ventricle, thus addressing the core mechanical failures in HFrEF. This approach not only improves cardiac output but also patient mobility and overall health stability.

Restore Medical, founded by experts including Stephen Bellomo (CTO), Dr. Elchanan Bruckheimer (Medical Director), and Aaron Feldman, and led by CEO Gilad Marom, operates with the backing of notable investors such as Peregrine Ventures and the European Innovation Council (EIC). Their collective expertise and innovative drive have positioned Restore Medical at the forefront of cardiac care technology.

The medical community has expressed optimism about the potential impact of ContraBand. Dr. Bruckheimer, Medical Director at Restore Medical, noted, “This designation from the FDA not only validates our technology but also accelerates our mission to provide groundbreaking solutions to patients with severe cardiac conditions who have limited treatment options.”