Restore Medical has received the prestigious Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its ContraBand™ System. This designation underscores the potential of Restore Medical’s technology to revolutionize the treatment of heart failure with reduced ejection fraction (HFrEF) patients.
The ContraBand™ System is designed to provide significant clinical benefits for heart failure patients, addressing a critical unmet medical need. Achieving the Breakthrough Device Designation not only validates the groundbreaking nature of Restore Medical’s technology but also facilitates a more efficient path to market, allowing the company to bring this life-changing treatment to patients more swiftly.
This milestone is a testament to Restore Medical’s dedication to innovation and excellence in the medical field.
