FDA Grants Breakthrough Designation for Revamp Medical’s Doraya Catheter

July 14, 2020—Revamp Medical announced that the FDA has granted Breakthrough Device designation for the Doraya device, a temporary intravenous catheter placed in the inferior vena cava below the renal veins for applying partial adjustable flow for up to 12 hours.

According to the company, the Doraya’s 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. By improving hemodynamics, namely cardiac preload and renal afterload, the device improves diuretic efficacy.

The Doraya is currently being evaluated in a first-in-human clinical study in Europe. The device is currently not approved for sale in any geography, advised Revamp Medical, which is based in Israel.

The FDA’s Breakthrough Devices Program is intended to expedite the agency’s review and approval of designated devices that may provide more effective treatment of life-threatening or irreversibly debilitating diseases. The FDA program is intended to help patients gain faster access by expediting designated device development, assessment, and review, while preserving the statutory standards for premarket approval, consistent with the FDA’s mission to protect and promote public health.