Vasospasm Indication Approved in Europe for Rapid Medical’s Comaneci Device

November 23, 2020—Rapid Medical, an Israel-based company focused on the development of next-generation neurovascular devices, announced CE Mark approval for the expanded indication of the Comaneci adjustable remodeling mesh device to treat cerebral vasospasm.

According to the company, Comaneci is designed to temporarily support vessels in the brain without occluding blood flow. It is used in procedures to assist in the coil embolization of wide-neck intracranial aneurysms. With this approval, Comaneci is now indicated for the mechanical dilation of intracranial vessels suffering from vasospasm.

The device is sequentially expanded, which allows the operator to gradually increase its applied force while also monitoring dilatation. Comaneci’s adjustable diameter, low delivery profile, and visibility may provide the ability to treat these patients more effectively and with a lower risk of vessel injury, stated the company.

“Comaneci's expanded indication for the endovascular treatment of vasospasm will provide physicians with an exciting new treatment option for our patients,” commented Hervé Brunel, MD, a senior interventional neuroradiologist at Marseille University Hospital, France.

In May 2019, Rapid Medical announced that its Comaneci device received FDA clearance as a temporary coil embolization assist device.