European regulators today recommended the suspension of Medtronic‘s (NYSE:MDT) Inductos bone growth product after inspections in July found problems with a U.S. plant that makes part of the implant.
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 did not immediately respond to a request for comment.
The post European regulators recommend suspension of Medtronic’s Inductos appeared first on MassDevice.
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