Codman Neuro's Revive SE Thrombectomy Device Approved in China, South Korea, and Taiwan

September 4, 2014—Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson, announced that the company’s Revive SE thrombectomy device has received regulatory approval from the China Food and Drug Administration, the South Korea Ministry of Food and Drug Safety, and the Taiwan Food and Drug Administration. 

The Revive SE thrombectomy device, which is also available in Europe, is 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. 

According to Codman Neuro, the Revive SE device is designed to ease navigation through small and tortuous blood vessels and arteries in the cerebral vasculature. It enables 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, as well as a narrow and tall strut design to better penetrate and engage more clot. Revive SE may be used for the nonsurgical removal of emboli and thrombi with aspiration and an injection or infusion of contrast media and other fluids.

Codman Neuro advised that Revive SE is not currently approved for distribution in the United States. However, the Revive PV peripheral vascular thrombectomy device is commercially available in the United States.