FDA approves new Temporary Aneurysm Embolization Assist Device

Rapid Medical, an Israeli company focused on the development of next generation neurovascular devices has announced that its Comaneci device received FDA clearance as a Temporary Coil Embolization Assist Device. The Comaneci is the first and only device in a new category of temporary coil embolization assist devices. 

The Comaneci is the first-ever adjustable, fully-visible aneurysm remodeling device. It acts as a temporary bridge used to aid in the coiling processes while minimizing the risk of coil protrusion or prolapse. Once the coiling procedure is completed the device is removed from the parent artery.

It is the only temporary coiling assist device that does not require parent vessel occlusion during coiling procedure or the need for long-term antiplatelet medication in case of permanent stenting. Until now the Comaneci have been successfully used in about 3,000 procedures outside the US.