Rapid Medical has announced that its adjustable remodelling mesh device, called Comaneci, has received CE mark approval. Comaneci is intended to treat cerebral vasospasm by mechanically dilating the intracranial vessels.
According to Rapid Medical’s press release, this is the first adjustable mesh device indicated for the endovascular treatment of vasospasm. Over 4,000 procedures have been performed utilizing the Comaneci device to assist in the coil embolization of wide-neck intracranial aneurysms.
During a cerebral vasospasm, spasms cause a narrowing of brain blood vessels, reducing blood flow. The traditional therapy for this problem has been balloon angioplasty, but according to their press release, this treatment carries the risk of balloons blocking blood flow and vessel perforation. According to the company, the Comaneci device temporarily supports vessels in the brain without occluding blood flow. The device is subsequently expanded, allowing clinicians to gradually increase its applied force, and monitor dilatation.
The company has stated that Comaneci’s adjustable diameter, low delivery profile and excellent visibility has the potential to treat patients more effectively with a lower risk of vessel injury.
Hervé Brunel, senior Interventional Neuroradiologist at Marseille University Hospital, France, said, “Comaneci’s expanded indication for the endovascular treatment of vasospasm will provide physicians with an exciting new treatment option for our patients,”