Elute Authorized for Clinical Trial of Antibiotic Eluting Bone Void Filler

By Julie A. Vetalice

Elute Authorized for Clinical Trial of Antibiotic Eluting Bone Void Filler

Elute, Inc., announced today it has received authorization from the US Food and Drug Administration (FDA) to use its EP Granules with Tobramycin™ in a pivotal clinical trial.

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.

This Investigational Device Exemption (IDE) authorization, involving the use of a resorbable bone void filler that delivers a broad-spectrum antibiotic in a local and targeted manner, is to investigate use in the surgical treatment of bone infections following hip or knee replacements. This is the first FDA authorization to use EP Granules with Tobramycin in patients with such difficult to treat bone infections.

Source: Elute, Inc.

Product Labels: Synthetic Bone Graft

Tags: Trial/Study