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# Revamp Gets Breakthrough Status for Heart Device
- URL: https://www.fdaweb.com/revamp-gets-breakthrough-status-for-heart-device/
- Published: 2020-07-14T12:00:00.000Z
- Updated: 2026-09-14T16:20:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147197

FDA has granted Revamp Medical a breakthrough device designation for its Doraya percutaneous device for treating acute heart failure (AHF). The temporary catheter, placed in the inferior vena cava below the renal veins, provides partial adjustable flow for up to 12 hours. “The device flow regulator mechanism is designed to temporarily reduce central venous pressure and improve diuretic response in hospitalized patients with acute heart failure with insufficient response to diuretic therapy,” the company says. The Doraya is currently being evaluated in a first-in-human clinical study in Europe on improving clinical outcomes in AHF patients with low response to diuretic therapy.