ATLANTA, July 31, 2024 /PRNewswire/ — MiRus has obtained Breakthrough Machine Designation from the FDA for the EUROPA® Posterior Cervical System, based mostly on it’s proprietary rhenium alloys, for remedy of the cervical and higher thoracic spine.
The EUROPA® PCF system is constructed round a 2.9 mm MoRe rod which is way smaller than present industrial techniques. The decrease diameter rod permits low-profile pedicle screw tulips resulting in much less invasive surgical procedure and fewer {hardware} prominence in smaller sufferers. Though decrease diameter, MoRe rods present a superior degree of rigidity, energy, and fatigue resistance which reduces the chance of spine rod fractures in comparison with present techniques.
“I’ve used the 4.5mm MoRe rod TL system for complicated circumstances and have had good outcomes,” acknowledged Han Jo Kim MD, Professor of Orthopedic Surgical procedure on the Hospital for Particular Surgical procedure, New York. “There’s large potential in what this proprietary alloy (MoRe) can accomplish in spine surgical procedure, providing implants which might be decrease profile, extra sturdy and stronger.”
Dr. Ankit Mehta, Affiliate Professor of Neurosurgery and Chief of Backbone at College of Illinois Chicago commented, “The ultra-low profile EUROPA® PCF system mixed with the sturdiness of the two.9mm MoRe rod permits for flexibility in inserting implants that beforehand couldn’t be achieved, permitting for higher fixation in these difficult circumstances. Decrease tulip quantity means extra room for the fusion mattress thereby enhancing fusion charges in sufferers.”
“At the moment the charges of spine implant failures and revision surgical procedures for sufferers stay unacceptably excessive,” commented Jordan Bauman, VP of Regulatory and High quality. “With EUROPA® PCF, spine surgeons will have the ability to present sturdy and fewer invasive surgical procedure for his or her cervicothoracic sufferers. That is one other step ahead in our mission to offer much less invasive and extra sturdy gadgets throughout a broad spectrum of illness states.”
About MiRus, LLC.
MiRus is a life sciences firm headquartered in Atlanta, Georgia that has developed and is commercializing proprietary novel biomaterials and implants which might be remodeling medication by making surgical procedures much less invasive and implants safer and extra sturdy. www.mirusmed.com.
Statements made on this press launch that look ahead in time or that categorical beliefs, expectations or hopes concerning future occurrences or anticipated outcomes are forward-looking statements. Quite a lot of dangers and uncertainties similar to dangers related to product growth and commercialization efforts, anticipated timing or outcomes of any medical trials, final medical final result and perceived or precise benefits of the Firm’s merchandise, market and doctor acceptance of the merchandise, mental property safety, and aggressive choices may trigger precise occasions to adversely differ from the expectations indicated in these ahead trying statements. The EUROPA® Posterior Cervical System will not be FDA authorised.
* MiRus® , EUROPA®, MoRe® are all logos of MiRus, LLC.
Contact:
Pam Cowart
VP of Scientific Affairs
pcowart@mirusmed.com
770-861-4804
SOURCE MiRus
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