Rapid Medical has announced US Food and Drug Administration (FDA) Breakthrough Device designation for its Comaneci embolisation assist technology, which is intended to facilitate the treatment of cerebral vasospasm—a major complication and cause of morbidity from subarachnoid haemorrhage—following a haemorrhagic stroke.
“We just need better solutions for patients—no single treatment has been shown to be uniformly safe and effective in treating symptomatic vasospasm,” said Brian Jankowitz (University of Pennsylvania, Philadelphia, USA). “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 available in Europe for vasospasm intervention and is showing promising results. In a 30-patient multicentre, 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. Additionally, more than 10,000 procedures have been performed worldwide utilising Comaneci to assist in the coil embolisation of wide-neck intracranial aneurysms.
The device’s adjustable diameter, low delivery profile and excellent visibility have drawn physicians around the globe to demand Comaneci, according to a Rapid press release. As a temporary device, it offers a treatment modality that may prevent the need for permanent devices implanted in the brain.
“This breakthrough designation will help expedite the availability of Comaneci, potentially providing a safer option for these sick patients,” added James Romero, president, Americas, at Rapid. “It underscores how we pioneer tools that provide physicians with greater control and expand treatment options tailored to patients.”