Rapid Medical has secured approval from the US Food and Drug Administration (FDA) for its Comaneci temporary coil embolization assist device.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
Comaneci is claimed to the first and only device in a new category of temporary coil embolization assist devices.
Comaneci, which is an adjustable and fully-visible aneurysm remodeling device, serves as a temporary bridge to assist in the coiling processes and minimize the risk of coil protrusion or prolapse.
The device will be removed from the parent artery, upon completion of the coiling procedure.
New York University School of Medicine radiology and neurosurgery departments professor Dr Peter Kim 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.”
Comaneci is said to be the only temporary coiling assist device, which does not require parent vessel occlusion during coiling procedure or the need for long-term antiplatelet medication in case of permanent stenting.
According to the company, the device has been successfully used in around 3,000 procedures outside the US.
Rapid Medical regulatory affairs vice president Dr Orit Yaniv said: “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.”
Rapid Medical is involved in the development of next generation neurovascular medical devices. The company produces TigerTriever, which is controllable and fully visible stentriever designed for the treatment of ischemic stroke patients.
Both TigerTriever and Comaneci secured CE mark approval to market in the European countries.
TigerTriever helps to adjust diameter to overcome excessive resistance during retrieval, and its single piece shaft and stent reduces risk of detachment. In addition, the device features radiopaque wires that provide realtime feedback.