Medical device company MiRus has won 510(k) approval from the US Food and Drug Administration (FDA) for MoRe based Europa Pedicle Screw System.
Image: MiRus secures 510(k) approval from FDA for new superalloy medical implant. Photo: Courtesy of yodiyim/FreeDigitalPhotos.net.
MiRus said that its MoRe stands for molybdenum rhenium superalloy for medical implants to provide a combination of strength, ductility, durability and biological safety, which is unmatched in the current materials.
MoRe based Europa Pedicle Screw System is claimed to be the first FDA approved medical device with a new class of implant material.
The company noted that the clinical needs of many patients remain unmet because of the limitations of titanium, cobalt and iron based alloys that were originally developed 40 years ago.
MoRe superalloy claims to allow for the design of new generation of smaller, stronger, more durable and bio-friendly implants that can result in less soft tissue disruption, quicker recovery and better outcomes for patients.
MiRus founder and CEO Jay Yadav said: “FDA approval of the Europa Pedicle Screw System with our patented MoRe superalloy is the culmination of over ten years of research and development. Our scientists and engineers working with world class metallurgists have created the greatest advance in medical implant material technology in at least four decades.
Yadav noted that the MoRe superalloy will revolutionize several aspects of the medical device industry as the first alloy approved by the FDA for use in an implant which is not based on titanium, cobalt or iron with their inherent limitations.
Yadav said: “In response to FDA guidance, our scientific team led by Regulatory vice president Jordan Bauman, developed a comprehensive body of evidence which served as the basis for approval of this major advance in patient care.”
Washington University Mildred B. Simon Distinguished Professor Orthopaedic Surgery, Adult/Pediatric Spinal Deformity service Director and Neurological Surgery Professor Munish Gupta said: “Spine deformity surgery in adults remains plagued by the poor performance of current implants with rod failure occurring in 18%-20% of patients. The MoRe alloy shows great promise in improving the durability of adult spine deformity constructs. This advance will help prevent early revision surgery and improve outcomes in adult deformity surgery in particular.”
Marietta, Georgia-based MiRus is a medical device company in the development of biomateirals, implants and software solutions for spine, orthopaedics and cardiovascular disease. The company aims to address today’s healthcare with an integrated platform of pre-operative planning and risk assessment tools, navigation and robotics system and post-operative monitoring and risk mitigation.