Movmedix, a French orthopedic company behind the LARS synthetic ligament platform, today announced that it has received its first FDA clearance, enabling the commercial launch of its LARS ACJ system in the United States.
Made from biocompatible polyethylene terephthalate (PET), LARS ACJ Implant is a third-generation synthetic implant, a knitted surgical scaffold in the form of a band intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. The device system also includes the LARS Screws and dedicated surgical instruments.
Today, LARS technologies support more than 11 clinical indications, have been implanted in more than 250,000 patients worldwide, and are supported by over 100 peer-reviewed scientific publications, making Movmedix one of the most extensively documented innovators in synthetic ligament reconstruction and reinforcement.
Following FDA clearance, Movmedix is preparing its entry into the U.S. market through a phased commercial strategy.
The company intends to establish a local presence and develop strategic partnerships to support the adoption of its technologies, while engaging with leading orthopedic surgeons and sports medicine specialists to advance clinical education and market development.
The FDA clearance of LARS ACJ also represents the beginning of a broader regulatory roadmap, with additional products from the LARS portfolio already planned for future FDA submissions.
