Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson, has announced regulatory approval from the China Food and Drug Administration (CFDA), South Korea’s Ministry of Food and Drug Safety (MFDS), and the Taiwan Food and Drug Administration (TFDA) for the company’s Revive SE Thrombectomy Device, a next-generation self-expanding clot removal device intended to restore blood flow in patients with acute ischaemic stroke secondary to intracranial occlusive vessel disease.
The Revive SE Device is designed to ease navigation through small and tortuous blood vessels and arteries in the cerebral vasculature. The new device enables rapid restoration of blood flow to the brain during an acute ischaemic stroke.
“We are pleased to offer the Revive SE device in these countries, which have a high incidence of stroke and an increasing need for new and advanced treatment options,” says P Laxmin Laxminarain, worldwide president of Codman Neuro. “Codman Neuro continues to expand its presence throughout the world with existing and new solutions that fill clinical needs and improve patient care.”
The Revive SE Device, which is also available in Europe, features a closed-ended soft distal tip to capture clots and large fragments with minimal trauma, and a narrow and tall strut design to better penetrate and engage more clot. Clinicians may use the Revive SE Device for the non-surgical removal of emboli and thrombi, with aspiration and with the injection or infusion of contrast media and other fluids.
The Revive SE Thrombectomy Device is not currently approved for distribution in the United States.