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# Breakthrough Status for Heart Failure Device
- URL: https://www.fdaweb.com/breakthrough-status-for-heart-failure-device/
- Published: 2024-07-18T12:00:00.000Z
- Updated: 2026-09-14T14:35:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157383

FDA has granted Restore Medical a breakthrough device designation for its ContraBand device and its use in treating heart failure with reduced ejection fraction (HFrEF) patients who remain symptomatic despite maximally tolerated guideline-directed medical therapy and who don’t have significant pulmonary hypertension or right heart failure. ContraBand is described as the “world's first transcatheter pulmonary artery banding (PAB) system” designed specifically for HFrEF patients to improve their quality of life.

The breakthrough designation was based on data from an ongoing feasibility study “demonstrating promising outcomes in safety and efficacy,” Restore says. “These results include significant left ventricular volume reduction, improved hemodynamic function, and enhanced physical capacity in patients treated with the ContraBand device.”