FDA clears first molybdenum rhenium pedicle screw

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...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance mirus Source Type: news