5. Revamp Medical: Doraya acute heart failure catheter
Revamp Medical won FDA breakthrough device designation for its Doraya acute heart failure catheter in July 2020. The device is a temporary intravenous catheter that is placed in the inferior vena cava below the renal veins and temporarily applies partial adjustable flow.
The device has a flow regulator mechanism that is designed to temporarily reduce central venous pressure and improve the diuretic response in patients with acute heart failure and insufficient response to diuretic therapy.
The manageable flow-reducing central venous catheter is deployed in the infrarenal IVC for up to 12 hours to help cardiologists temporarily manage venous hemodynamics, central venous pressure, renal afterload and venous returns.