FDA Clears Rapid Medical's Comaneci Temporary Aneurysm Embolization Assist Device
May 7, 2019—Rapid Medical announced that its Comaneci device received FDA clearance as a temporary coil embolization assist device.
According to the company, the Comaneci is an adjustable, fully visible aneurysm remodeling device that acts as a temporary bridge used to aid in the coiling processes while minimizing the risk of coil protrusion or prolapse. When the coiling procedure is completed, the device is removed from the parent artery. The device does not require parent vessel occlusion during the coiling procedure or the need for long-term antiplatelet medication in case of permanent stenting.
Peter Kim Nelson, MD, commented in Rapid Medical's announcement, "I am excited about having the Comaneci in the United States. 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. Nelson is a professor in the Departments of Radiology and Neurosurgery at the New York University School of Medicine and Chief of the Bernard and Irene Schwartz Interventional Neuroradiology Section at NYU Langone Health system in New York, New York.
Comaneci is the company's first device available in the United States. Rapid Medical's Tigertriever is a controllable, fully visible stentriever designed to treat patients with ischemic stroke. Both the Comaneci and Tigertriever have CE Mark approval for use in Europe.