Rapid Medical said today that it won FDA 510(k) clearance for its Comaneci device, now cleared as a temporary coil embolization assist system.
The Israel-based company said that the Comaneci is the first and only device cleared by the FDA in a new category of temporary coil embolization assist devices.
The Comaneci is an adjustable, fully-visible aneurysm remodeling device intended to act as a temporary bridge to aid in the coiling process and minimize the risk of coil protrusion or prolapse. Once coiling is complete, the Comaneci device is removed form the parent artery, Rapid Medical said.
“I am excited about having the Comaneci in the US. It should be a valuable alternative for ruptured and unruptured wide neck aneurysms, typically requiring balloon assistance for coil embolization, since it provides temporary protection of the parent artery during aneurysm coiling without arresting flow,” Dr. Peter Kim Nelson of the NYU Langone Health system said in a prepared statement.
The company touted that the device is the only temporary coiling assist device that does not require parent vessel occlusion during coiling procedures or the need for long-term antiplatelet medication for permanent stenting.
“We are extremely pleased by FDA’s clearance of the Comaneci device, which will be our first device available in the US. We want to thank the FDA team for their efforts during the review process to bring it to a successful completion,” regulatory affairs VP Dr. Orit Yaniv said in a press release.
Last month, MicroPort Scientific has joined a $20 million Series C round for Rapid Medical.