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# Breakthrough Status for Heart Failure Device
- URL: https://www.fdaweb.com/breakthrough-status-for-heart-failure-device-2/
- Published: 2025-01-09T12:00:00.000Z
- Updated: 2026-09-14T14:50:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158463

FDA has granted Alleviant Medical a breakthrough designation for its no-implant atrial shunt technology for treating heart failure with reduced ejection fraction (HFrEF). The agency also approved the company’s investigational device exemption application for it to begin a pivotal trial focused on (HFrEF) patients, according to the company. The trial is designed to test the novel device, which creates an atrial shunt but leaves no permanent implant behind, it says.

The company says the trial will evaluate the safety and effectiveness of the Alleviant System in heart failure patients with reduced left ventricular ejection fraction who remain symptomatic despite guideline-directed medical therapy. The trial will have an adaptive design and will begin enrolling about 350 randomized patients at select sites globally early this year, it adds.