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FDA grants breakthrough nod for Rapid Medical’s embolization assist device

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Rapid Medical Comenaci
[Image from Rapid Medical]
Rapid Medical announced today that it received FDA breakthrough device designation for its Comaneci embolization assist device.

Yokneam, Israel-based Rapid Medical designed the Comaneci embolization device to facilitate the treatment of cerebral vasospasm following hemorrhagic stroke.

In a news release, the company touted clinical results for the platform, which is already available in Europe for vasospasm intervention. In a 30-patient multi-center retrospective analysis, 97% of patients showed an increase in vessel opening of at least 25%, while 80% showed an increase of 50% or more.

Rapid Medical noted that more than 10,000 procedures have been performed worldwide with Comaneci assisting in the coil embolization of wide-neck intracranial aneurysms.

The company touts features such as an adjustable diameter, low delivery profile and strong visibility, with the temporary device offering 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,” Rapid Medical President of the Americas James Romero said in the release. “It underscores how we pioneer tools that provide physicians with greater control and expand treatment options tailored to patients.”

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