Elute Receives FDA Authorization For Its First Clinical Trial Using Antibiotic Eluting Bone Void Filler
June 11, 2021
Elute has received an Investigational Device Exemption (IDE) authorization from the FDA to use its EP Granules with TobramycinTM in a pivotal clinical trial. This IDE investigates the use of a resorbable bone void filler that delivers a broad-spectrum antibiotic in the surgical treatment of bone infections following hip or knee replacements. This is the first FDA authorization to use EP Granules with Tobramycin to treat difficult bone infections.
“BioUtah congratulates the Elute team on this significant milestone” said Kelvyn Cullimore, president and CEO of BioUtah. “This clinical trial and the company’s novel drug eluting device is taking direct aim at addressing a critical unmet healthcare need.”
EP Granules with Tobramycin is a synthetic calcium-salt resorbable bone void filler that is designed to provide 8-week delivery of an antibiotic in a local targeted region while allowing growth of new bone.
“We are pleased to note that the supporting pre-clinical data including safety and efficacy studies of EP Granules with Tobramycin we presented to the FDA merited the approval of our IDE. We believe that the authorization of this randomized, blinded, prospectively controlled IDE clinical evaluation will enable further evaluation of this new product to support a future premarket submission, with significant potential to improve patient care and satisfaction,” said Dr. Ashok Khandkar, president and CEO of Elute.
“We are committed to expediting the development and availability of novel solutions that address unmet needs in treating bone infections,” added Denny Farrar, executive chairman of Elute.
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