Rapid Medical’s Vasospasm Treatment Earns Breakthrough Status

Neurovascular device maker Rapid Medical has earned U.S. Food and Drug Administration (FDA) breakthrough designation for its Comaneci embolization assist device to help treat cerebral vasospasm after a hemorrhagic stroke. Vasospasm is a major complication and cause of morbidity.
 
“We just need better solutions for patients–no single treatment has been shown to be uniformly safe and effective in treating symptomatic vasospasm,” Brian Jankowitz, M.D., a neurosurgeon at the University of Pennsylvania told the press. “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 is already available in Europe for vasospasm intervention. A 30-patient retrospective analysis of the device showed 97 percent of patients showed a vessel opening increase of at least 25 percent. 80 percent of patients showed an increase of 50 percent or more¹.
 
Woldwide, over 10,000 procedures have been performed using Comaneci to assist in coil embolization of wide-neck intercranial aneurysms. Using it may prevent the need for permanent implants in the brain.
 
“This breakthrough designation will help expedite the availability of Comaneci, potentially providing a safer option for these sick patients, described 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.”
 
Reference
¹ Data on file at Rapid Medical from centers in Germany, Spain, Switzerland, France, and USA.