MiRus™ Receives FDA 510(k) Clearance for CYGNUS™ Anterior Cervical Plate
ATLANTA, July 26, 2019 /PRNewswire/ — MiRus is pleased to announce recent FDA 510(k) clearance of the CYGNUS™ Anterior Cervical Plate System, the narrowest and thinnest cervical plate on the market. The unique I-beam design and metal alloy used in the plate allows for a dramatically smaller footprint without sacrificing performance. The CYGNUS™ Anterior Cervical Plate with its narrower profile will lead to less retraction and anterior vertebral body preparation resulting in shorter operative times and minimizing risk of complications such as dysphagia and dysphonia in patients undergoing anterior cervical fusion.
“The CYGNUS plate is remarkably thin and strong making it easy to implant with unparalleled graft visualization,” stated Brian Scholl, MD, orthopaedic surgeon at The Orthopaedic Center, Huntsville, Alabama. “It truly represents a leap forward in implant design and metals technology.”
Dmitri Sofianos, MD, orthopaedic surgeon at Chatham Orthopaedic Associates, Savannah, GA commented, “The CYGNUS plate from MiRus is unique in almost every way. The new molybdenum alloy has allowed for a completely innovative and remarkably thin yet sturdy I-beam construction design that will not only reduce surgical implant time but improve patient outcomes.“
“The approval of the CYGNUS Anterior Cervical Plate System is yet another major accomplishment as we strive to develop products that are best in class with resolve to improve patient outcomes and provide surgeons with premium products. I am enthusiastic to introduce a world class product into the ACDF marketplace that is well established and lacks innovative products such as the CYGNUS Anterior Cervical Plate,” remarked Wayne Gray, Senior Director R&D, Implant Systems.
About MiRus, LLC.
MiRus is a medical device company that has developed and is commercializing proprietary novel biomaterials, implants and software solutions for spine, orthopaedics and cardiovascular disease. We are addressing the demands of today’s healthcare environment with an integrated platform of pre-operative planning and risk assessment tools, a breakthrough navigation and robotics system and post-operative monitoring and risk mitigation. Find more information about MiRus at www.mirusmed.com.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.
CYGNUS™ and MiRus™ are trademarks of MiRus, LLC.
VP, Sales and Marketing, MiRus