Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson, has gained Chinese (CFDA) South Korean (MFDS) and Taiwanese (TFDA) regulatory approval for its REVIVE™ SE Thrombectomy Device, a next-generation self-expanding clot removal device intended to restore blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease.
Stroke is China’s leading cause of death and disability, with a staggering two and half million victims each year. No wonder Codman is keen to get its thrombectomy device on the market there and across the Far East.
Codman’s 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 ischemic stroke.
Already available in Europe for over a year now, the device features a closed-ended soft distal tip to capture clots and large fragments with minimal trauma, and a narrow and tall strut, all designed 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, although the REVIVE PV (Peripheral Vascular) Thrombectomy Device is commercially available there. The REVIVE PV Thrombectomy Device is designed to restore blood flow via non-surgical removal of emboli and thrombi from peripheral blood vessels, such as those found in peripheral artery disease (PAD).
“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,” said 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.”
Source: Codman Neuro