Devices Interventional FDA

 News Release - May 7, 2019

Rapid Medical Announces FDA Approval of Novel Temporary Aneurysm Embolization Assist Device

Comaneci - the only non-vessel-occluding temporary intracranial coiling embolization assist device

YOKNEAM, Israel, May 7, 2019 -- (Healthcare Sales & Marketing Network) -- Rapid Medical, a company focused on the development of next generation neurovascular devices, today 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.

"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," said Peter Kim Nelson, MD, Professor in the Departments of Radiology and Neurosurgery in the New York University School of Medicine and Chief of the Bernard and Irene Schwartz Interventional Neuroradiology Section within the NYU Langone Health system.

"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," said Dr. Orit Yaniv, VP of Regulatory Affairs at Rapid Medical.

About Rapid Medical

Rapid Medical is developing game-changing devices for endovascular treatments. Rapid Medical is the maker of TIGERTRIEVER, the first-ever controllable, fully visible stentriever that is designed to treat ischemic stroke patients, and, COMANECI, the first-ever controllable aneurysm neck-bridging device. TIGERTRIEVER and COMANECI are CE marked for use in Europe. More information is available at www.rapid-medical.com.

Source: Rapid Medical

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