Rapid Medical, a company focused on the development of next-generation neurovascular devices, has announced CE Mark approval for the expanded indication of Comaneci to treat cerebral vasospasm.
Comaneci is the first adjustable remodeling mesh device designed to temporarily support vessels in the brain without occluding blood flow. Over 4,000 procedures have been performed utilizing Comaneci 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.
Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage, a type of hemorrhagic stroke. The spasms cause a narrowing of the brain blood vessels, reducing blood flow. This occurs in 70% of patients and leads to neurological deterioration in up to 30%1. Balloon angioplasty has been the main therapy for these symptomatic patients, but balloons block blood flow to the already ischemic brain tissue and carry a risk of vessel perforation. Conversely, the Comaneci device is sequentially expanded, allowing the operator to gradually increase its applied force while also monitoring dilatation. This adjustable diameter, low delivery profile and excellent visibility have drawn physicians around the globe to demand Comaneci for vasospasm treatment as it may provide the ability to treat these patients more effectively and with a lower risk of vessel injury.
“Comaneci’s expanded indication for the endovascular treatment of vasospasm will provide physicians with an exciting new treatment option for our patients,” said Dr. Hervé Brunel, a senior Interventional Neuroradiologist at Marseille University Hospital, France.
Dr. Walid Haddad, Rapid Medical’s Chief Clinical Officer, added, “Initial data collected from our procedures in Europe suggest Comaneci’s safe and successful performance in the mechanical dilation of intracranial vasospastic vessels. Mechanical dilation was successful in almost all cases and was typically accompanied by significant neurological improvement. I believe that this procedure can meaningfully improve the patient outcomes of this severe disease.”