Massachusetts-based Codman Neuro is preparing to take Asia Pacific by storm with new regulatory wins in China, South Korea and Taiwan for the company’s Revive SE thrombectomy device.
The three countries approved the Revive SE system for non-surgical removal of blood clots in patients with acute ischemic stroke, the company said. The Revive SE device is designed to help surgeons get through narrow and complex vessels where debris may get trapped and block blood flow.
Revive SE is not yet on the market in the U.S., but the related Revive PV system has the FDA’s seal of approval to aid in non-surgical removal of blood clots in peripheral blood vessels.
In a separate release Codman, a subsidiary of Johnson & Johnson’s (NYSE:JNJ) DePuy Synthes division, also announced that it landed exclusive rights from Pulsar Vascular to distribute the PulseRider aneurysm reconstruction device in Europe, the Middle East and Africa.
The PulseRider system is a minimally invasive device designed for use with embolic coils to treat wide-necked, un-ruptured aneurysms in the brain. The device has had European approval since late last year, but is limited to investigational use in the U.S., according to a press release.