Comaneci Embolization Assist Device Gets FDA Breakthrough Designation

US FDA breakthrough Designation has been granted to Rapid Medical for its Comaneci embolization assist device to facilitate the treatment of cerebral vasospasm following hemorrhagic stroke. Vasospasm is a major complication and cause of morbidity. The FDA’s Breakthrough Device Program is designed to give patients more timely access to novel technologies that provide more effective treatments for life-threatening or irreversibly debilitating human diseases and conditions.

“We just need better solutions for patients–no single treatment has been shown to be uniformly safe and effective in treating symptomatic vasospasm,” comments Brian Jankowitz, MD, a neurosurgeon at the University of Pennsylvania. “Comaneci is the first device to provide combination therapy to the brain with an adjustable diameter/radial force that may lower the risk of vessel injury.”

Comaneci, available in Europe for vasospasm intervention, is showing promising results. In a 30-patient multi-center retrospective analysis, 97% of patients showed an increase in vessel opening of at least 25%, with 80% of patients showing an increase of 50% or more, according to the company. Additionally, over 10,000 procedures have been performed world-wide utilizing Comaneci to assist in the coil embolization of wide-neck intracranial aneurysms. Comaneci’s adjustable diameter, low delivery profile and excellent visibility have drawn physicians around the globe to demand Comaneci. As a temporary device, it offers a treatment modality that may prevent the need for permanent devices implanted in the brain.

Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage. The spasms cause a narrowing of the brain blood vessels, reducing blood flow and leading to the death of brain tissue. This occurs in 70% of patients and leads to neurological deterioration in up to 30%, based on the results of a June 2020 paper in International Neuroradiology.

“This breakthrough designation will help expedite the availability of Comaneci, potentially providing a safer option for these sick patients, describes James Romero, President, Americas, at Rapid Medical. “It underscores how we pioneer tools that provide physicians with greater control and expand treatment options tailored to patients.”