The Doraya is a temporary intravenous catheter designed to help cardiologists enhance haemodynamics
Revamp Medical has secured FDA breakthrough device status for Doraya AHF device. (Credit: Raman Oza from Pixabay)
Israel-based Revamp Medical has secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its Doraya acute heart failure (AHF) device.
The Doraya is a temporary catheter that will be placed in the inferior vena cava below the renal veins by applying an adjustable flow for up to 12 hours.
The device flow regulator mechanism will help to temporarily decrease central venous pressure and enhance diuretic response in hospitalised patients with acute heart failure with insufficient response to diuretic therapy.
Doraya device is being assessed in a human clinical study in Europe
Revamp’s Doraya is being assessed in a first in human clinical study in Europe with the aim of improving clinical outcomes of AHF patients with low response to diuretic therapy.
The Doraya is a temporary intravenous catheter, which will help cardiologists to enhance haemodynamics, known as cardiac preload and renal afterload, to optimise diuretic efficacy.
Heart failure is a chronic and progressive disease, which is said to affect over six million adults and causing more than one million annual hospitalisations in the US alone, said the company.
Revamp Medical CEO Lihu Avitov said: “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.
“As we begin to accelerate our clinical development program in the US, we plan to leverage the benefits of FDA Breakthrough Device Designation.”
Based in Netanya, Revamp Medical is engaged in the development of a catheter-based device for the better treatment of the acute heart failure population.
In June, Royal Philips secured premarket approval (PMA) from the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) for its HeartStart FR3 and HeartStart FRx automated external defibrillators.