The European Medicines Agency recommended that the suspension be put in place until the problems are resolved. Dutch and Spanish inspectors found that the sponge manufacturer “did not have adequate measures in place to prevent particle contamination of the sponges,” the EMA said.
“Although there is no indication of risk to patients linked to the inspection findings, EMA’s Committee for Medicinal Products for Human Use considered that the quality of Inductos cannot be assured with the current manufacturing process. The CHMP therefore concluded that Inductos should be suspended until the manufacturing issues are satisfactorily addressed,” the agency said.
Inductos, which is a kit containing a powder, solvent and absorbable collagen sponge, is used to stimulate bone growth in leg and spine surgeries using the bone-growth-stimulating protein dibotermin alfa.
The EMA’s recommendation is slated to be sent to the European Commission for a final decision.
Medtronic told MassDevice.com via email that it’s in “regular contact” with the 3rd-party manufacturer of the sponge component and is working on a remediation plan.
“We expect their facility to be up and running soon,” the company wrote, noting that the EMA action only affects Inductos distribution in Europe.