QNotes, Vol. 10, Issue 4
Qmetrics Technologies today announced that its medical imaging expertise assisted Elute, Inc. in receiving approval from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) to use its EP Granules with Tobramycin™ in a pivotal clinical trial. Elute announced the approval of the IDE in June and its plans for the clinical trial are underway.
This 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 bone infections.
“We were excited when Elute reached out to us to potentially support the imaging component of a prospective trial,” commented Edward Schreyer, CEO, Qmetrics Technologies. “With our expertise in medical imaging, we knew we could be of help to them. We help our partners to develop the best protocols to obtain robust data from imaging.” Qmetrics assisted in developing a standardized approach to using x-ray imaging to assess bone growth, along with a CT sub-study to validate the x-ray approach.
“We were pleased to have discussions with the Qmetrics team of experts with their clinical and technical understanding of the requirements for musculoskeletal radiographic image scoring and development and validation of quantitative bone growth measures for use in musculoskeletal radiology studies.,’ said Dr. Ashok Khandkar, President and CEO, Elute, Inc. “Their involvement was an important contribution to our IDE application.”