CE Mark For Codman Neuro’s Enhanced Navigation REVIVE SE™ Thrombectomy Device

Codman Neuro-REVIVE SECodman 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.

Background

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.1 The new strut design also lowers the force required to track the device through a 0.021 micro-catheter.2

Physician comments

”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 and paid consultant to the company. “The new device offers good navigation, and based on procedures with its predecessor device, provides consistently good recanalization rates and outcomes.”3

Company comments

“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.”

Regulatory status

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.

References

1 Data on file at Codman Neuro

2 Test reports on file at Codman Neuro

3 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

Source: Codman Neuro