Codman Neuro Obtains CE Mark For Enhanced REVIVE SE™ Thrombectomy Device
Self-Expanding Clot Removal Device for Ischemic Stroke Features Newly Enhanced Navigation
PARIS, FRANCE– JUNE 13, 2013 – Codman Neuro*, part of DePuy Synthes Companies of Johnson & Johnson, has obtained CE marking for REVIVE SE, a next-generation self-expanding clot removal device for use in treating acute ischemic stroke, the company announced today at the Live Interventional Neuroradiology & Neurosurgery Course (LINNC) in Paris.
The REVIVE SE device is a self-expanding nitinol basket that is designed to ease navigation through small and tortuous blood vessels and arteries in the cerebral vasculature, and enable rapid restoration of blood flow to the brain during an acute ischemic stroke.
The device 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] The new strut design also lowers the force required to track the device through a 0.021 micro-catheter.[ii]
”Ease of navigation is extremely important during a procedure like thrombectomy in terms of safety and time savings,” said Martin Bendszus, MD, Department of Neuroradiology, University of Heidelberg in Germany.** ”The new device offers good navigation, and based on procedures with its predecessor device, provides consistently good recanalization rates and outcomes.”[iii]
CE marking for the first generation REVIVE SE device was obtained in February 2011. In addition to clot removal, clinicians can use the REVIVE SE devices for the non-surgical removal of emboli and thrombi, with aspiration and with the injection or infusion of contrast media and other fluids. The devices are not currently approved for distribution in the United States.
“We are pleased to enhance our technology platform for ischemic stroke in a way that improves the overall clinical experience,” said P. Laxmin Laxminarain, Worldwide President of Codman Neuro. ”Clinicians told us enhanced navigation was important to them and we have responded with the next generation REVIVE SE.”
According to the World Stroke Organization, about 15 million people worldwide suffer a stroke each year and 5.8 million people die from it. It is the second leading cause of death for people over age 60 and a leading cause of disability throughout the world. The group says current trends suggest that the number of annual deaths will climb to 6.7 million by 2015 without appropriate action.[iv]
About Codman Neuro
Codman Neuro is a global neurosurgery, neurovascular and neuromodulation 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.com and www.depuysynthes.com for more information.
* Codman Neuro is a division of DePuy Orthopaedics, Inc.
** Prof Bend
[i] Data on file at Codman Neuro
[ii] Test reports on file at Codman Neuro
[iii]REVIVE™ SE Thrombectomy Device First in Man case series (data courtesy of Prof Martin Bendszus, University of Heidelberg,Germany and Prof Jens Fiehler, UKE Hamburg, Germany); Leeds General Infirmary Case Series ((data courtesy of Dr Tony Goddard, Leeds General Infirmary, UK); RIVER1 study