Philadelphia-based Rothman Orthopaedic Institute and New York City-based Hospital for Special Surgery became clinical sites to evaluate the safety and efficacy of an antibiotic-loaded bone void filler.
The product, Elute's EP Granules with Tobramycin, is a synthetic bone filler that provides an eight-week delivery of an antibiotic while allowing bone growth, according to a Nov. 30 news release. Orthopedic surgeons Amar Ranawat, MD, of HSS and Javad Parvizi, MD, of Rothman are clinical partners in the trial.
The trials come after EP Granules with Tobramycin received investigational device exemption authorization from the FDA.