Rapid Medical’s Comaneci Embolization Assist Device Receives FDA Breakthrough Designation to Treat Cerebral Vasospasm

February 15, 2022—Rapid Medical announced it has received FDA Breakthrough Device designation for Comaneci, the company’s embolization assist device intended to facilitate treatment of cerebral vasospasm after hemorrhagic stroke. The device is currently available in Europe for vasospasm intervention.

According to the company, the Comaneci features an adjustable diameter, low delivery profile, and good visibility, and allows physicians to monitor vessel expansion, apply incremental adjustments, and enhance treatment with combination therapeutics.

As a temporary device, the company also noted that it offers a treatment modality that could prevent the need for permanent devices implanted in the brain.

“We just need better solutions for patients—no single treatment has been shown to be uniformly safe and effective in treating symptomatic vasospasm,” commented Brian Jankowitz, MD, a neurosurgeon at the University of Pennsylvania in Philadelphia, 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.”

Rapid Medical reported that in a multicenter retrospective analysis of 30 patients, 97% showed an increase in vessel opening of ≥ 25%, and 80% showed an increase of ≥ 50%. Additionally, > 10,000 procedures worldwide have used Comaneci to assist in coil embolization of wide-neck intracranial aneurysms.

James Romero, President, Americas, at Rapid Medical, noted that Breakthrough Device designation will expedite the arrival of Comenanci and remarked, “It underscores how we pioneer tools that provide physicians with greater control and expand treatment options tailored to patients.”

The FDA 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.