Revamp Medical has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Doraya device, a temporary intravenous catheter.
The device flow regulator mechanism is designed to temporarily reduce Central Venous Pressure and improve diuretic response in hospitalised patients with acute heart failure with insufficient response to diuretic therapy. The Doraya is currently being evaluated in a first in-human clinical study in Europe, aiming to improve clinical outcomes of AHF patients with low response to diuretic therapy.
The Breakthrough Devices Program (BDP) is intended to expedite the FDA review and approval of designated devices that may provide more effective treatment of life-threatening or irreversibly debilitating diseases. BDP 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.
The Doraya is a temporary intravenous catheter, designed to allow cardiologists to improve haemodynamics, namely cardiac preload and renal afterload, to improve diuretic efficacy.
“Worsening Renal Function is a major challenge in the treatment of acute heart failure. We hope to provide cardiologists with a valuable tool to improve care of insufficient diuretic responder patients, in hopes of resetting the ‘cardiorenal clock,’” commented Lihu Avitov, Revamp Medical CEO. “As we begin to accelerate our clinical development program in the USA, we plan to leverage the benefits of FDA Breakthrough Device Designation.”