An adjustable endovascular device facilitates mechanical dilation of intracranial vessels suffering from vasospasm.

The Rapid Medical (Yokneam, Israel) Comaneci adjustable remodeling mesh is a fully-visible wire stent, primarily intended for aneurysm, that is permanently affixed to the end of an internal core wire for delivery via an endovascular approach; once positioned, the wire is withdrawn distally, thus expanding the mesh, creating radial dilation of the contracted intracranial vessel. As the expansion is sequential, users can gradually increase the applied force while monitoring dilatation, thus lowering the risk of vessel injury.

Features include a non-occlusive design that maintains blood supply to the brain; stable positioning; high vessel compliance; microcatheter support; adjustable proprietary FlexiBraid technology to provide incremental shaping control; and 100% radiopaque wires that provide realtime feedback. Three sizes are available: Comaneci, with a length of 32 mm, for vessels with a diameter of 1.5-4.5 mm; Comaneci Petit, with a length of 24 mm, suitable for vessels with a diameter of 1.5-3.5 mm; and the Comaneci 17, with a length of 22 mm, suitable for vessels with a diameter of 0.5-3 mm.

“Data collected from our procedures in Europe suggest Comaneci's safe and successful performance in the mechanical dilation of intracranial vasospastic vessels,” said Walid Haddad, MD, chief clinical officer of Rapid Medical. “Mechanical dilation was successful in almost all cases, and was typically accompanied by significant neurological improvement. I believe that this procedure can meaningfully improve patient outcomes of this severe disease.”

Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage, a type of hemorrhagic stroke. The spasms cause a narrowing of brain blood vessels, reducing blood flow. This occurs in 70% of patients and leads to neurological deterioration in up to 30%. Balloon angioplasty has so far been the main therapy for symptomatic patients, but such balloons block blood flow to the already ischemic brain tissue and also carry a risk of vessel perforation.

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