- Comaneci - the only non-vessel-occluding temporary intracranial coiling 
embolization assist device 
    
    Rapid Medical [https://www.rapid-medical.com/], 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. 
    
    Contact:
    Ronen Eckhouse
    +972-72-2503331   
    ronen@rapid-medical.com

    Source: Rapid Medical