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The Europa Pedicle Screw System received FDA 510(k) approval at the end of March. It is the first of its kind to contain a superalloy called molybdenum rhenium superalloy (MoRe) which is designed for a stronger, more durable medical implant. This is said to allow for quicker recovery than the decades old titanium, cobalt and iron-based products currently in use.
“Spine deformity surgery in adults remains plagued by the poor performance of current implants with rod failure occurring in 18-20 percent of patients,” said Munish Gupta, professor of orthopaedic surgery at Washington University, “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.”
Other surgeons, including James Nunley from Duke and Peter Newton from Rady Children’s Medical Practice Foundation also expressed their hope for the new product to help them design better solutions for their patients.
The approval comes after over a decade of research and work, according to MiRus CEO Jay Yadav.
“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,” Yadav said. “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.”
Yadav hopes to advance the superalloy into more areas, including cardiovascular areas of medicine.
