Revamp Medical, a medical device company developing a percutaneous device for the treatment of acute heart failure (AHF), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Doraya™ device. The Doraya is a temporary catheter, placed in the Inferior Vena Cava below the renal veins, applying 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 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.
Heart failure is a chronic and progressive disease, affecting more than 6 million adults and resulting in over 1 million annual hospitalizations in the US alone. Advanced Heart Failure is marked by frequent episodes of acute decompensation (fluid overload), typically requiring hospitalization for stabilization and improvement in symptoms. Failure to respond adequately to diuretic therapy is a common clinical problem, correlated to adverse outcomes in patients, increased length of hospital stays, and higher 30 days readmission rates.
The Doraya is a temporary intravenous catheter, designed to allow cardiologists to improve hemodynamics, 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 US, we plan to leverage the benefits of FDA Breakthrough Device Designation.”