Summary: Restore Medical’s ContraBand device received FDA Breakthrough Device Designation for treating heart failure with reduced ejection fraction (HFrEF) in patients unresponsive to standard therapies. This minimally invasive pulmonary artery banding system has shown promising results in improving heart function and patient quality of life.

Key Takeaways:

  • FDA Breakthrough Designation: Restore Medical’s ContraBand device received Breakthrough Device Designation for its potential to treat HFrEF patients who remain symptomatic despite standard therapies.
  • Positive Study Results: The designation was based on feasibility study results showing significant improvements in left ventricular volume, hemodynamic function, and patient physical capacity.

Restore Medical announced that it has been granted Breakthrough Device Designation by the U.S. FDA for its ContraBand device.

ContraBand Device and Procedure

The Breakthrough Device Designation was granted specifically for the treatment of heart failure with reduced ejection fraction (HFrEF) patients who remain symptomatic despite maximally tolerated guideline-directed medical therapy, without significant pulmonary hypertension or right heart failure.

ContraBand is a transcatheter Pulmonary Artery Banding (PAB) system designed specifically for HFrEF patients with the aim of improving the quality of life for these patients. The minimally invasive procedure is designed for patients suffering from left ventricle failure who currently have limited treatment options.

Basis for ContraBand Designation

FDA’s decision to grant Breakthrough Device Designation was based on positive results from an ongoing feasibility study demonstrating promising outcomes in safety and efficacy. These results include significant left ventricular volume reduction, improved hemodynamic function, and enhanced physical capacity in patients treated with the ContraBand device.

Program Intent and Potential Impact

FDA’s Breakthrough Device Designation program is intended to expedite the development and review of medical devices that offer significant advantages over existing treatments for serious or life-threatening conditions. Restore Medical said the designation highlights the potential of the ContraBand device to address critical unmet needs in the treatment of HFrEF patients.