RAYNHAM, Mass. — Codman Neuro*, part of DePuy Synthes Companies of Johnson & Johnson, 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 ischemic 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 ischemic 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," 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."
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.i 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 . The REVIVE PV (Peripheral Vascular) Thrombectomy Device is commercially available in the United States . 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).
About 2.5 million people in China suffer a stroke each year. It is the country’s leading cause of death and disability.ii In South Korea, there are nearly 800,000 new cases of stroke annually.iii Stroke mortality in Taiwan is approximately 2,300 per 100,000 among individuals aged 50–90 years.iv According to the World Stroke Organization, about 15 million people worldwide suffer a stroke each yearv and 6.2 million people die from it.vi It is the second leading cause of death for people over age 60 and a leading cause of disability throughout the world.
About Codman Neuro
Codman Neuro is a global neurosurgery and neurovascular company that offers a broad portfolio of devices for hydrocephalus management, neuro intensive care and cranial surgery as well as aneurysm coils, vascular reconstruction devices and other technologies used in the endovascular treatment of cerebral aneurysms and stroke. Codman Neuro is part of DePuy Synthes Companies of Johnson & Johnson. Visit www.codman.comand www.depuysynthes.com for more information.
*Codman Neuro is a division of DePuy Orthopaedics, Inc.
i Data on file at Codman Neuro
ii http://stroke.ahajournals.org/content/42/12/3651.full –Accessed Aug. 2014
iii http://stroke.ahajournals.org/cgi/content/meeting_abstract/44/2_MeetingAbstracts/AWP203 — accessed Aug. 2014
iv http://informahealthcare.com/doi/abs/10.3109/00207454.2013.796552 –accessed Aug. 2014.
vi http://www.worldstrokecampaign.org/learn/facts-and-figures.html — Accessed Aug. 2014
©Codman Neuro, a division of DOI 2014. All rights reserved.
Press release via Codman Neuro.