The FDA today cleared Mirus‘s Europea pedicle screw system, which is composed of its MoRe proprietary molybdenum rhenium superalloy, making it the first such device approved with the new class of implant material.
The Atlanta-based medical device company said that the MoRe proprietary alloy is intended to provide improved strength, ductility, durability and biological safety.
“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,” Dr. Munish Gupta of Washington University said in a press release.
“This new material with its greater strength, fatigue resistance and superior biological properties will allow us to make lower profile foot and ankle implants leading to smaller surgical exposures and reduced revision rates,” Dr. James Nunley of Duke University said in a prepared statement.
Mirus added that it believes the MoRe alloy will allow for a new generation of smaller, stronger, more durable and bio-friendly implants which it hopes will result in less tissue disruption, faster recovery and improved patient outcomes.
“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. The MoRe superalloy will revolutionize many 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. The FDA requires a rigorous level of scientific investigation to establish the safety and effectiveness of a spine implant that utilizes a new medical alloy. In response to FDA guidance, our scientific team led by Jordan Bauman, VP of Regulatory, developed a comprehensive body of evidence which served as the basis for approval of this major advance in patient care. We are fortunate to be collaborating with an outstanding worldwide group of orthopaedic and neurosurgeons in developing transformative spine solutions. Additionally, MiRus is rapidly expanding into other orthopaedic applications such as foot and ankle and has made significant progress in cardiovascular applications of the MoRe® superalloy,” founder & CEO Dr. Jay Yadav said in prepared remarks.
Source : Massdevice , 27 March 2019
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