Roughly three months after the European Medicines Agency announced it was seeking additional information on the InductOs implant marketed by a Medtronic unit, the health body has recommended the suspension of the product.
The EMA launched a review of InductOs, which is used to help new bone develop in patients with spinal disc problems and leg fractures, following an inspection by Dutch and Spanish authorities determined that Integra LifeSciences, the U.S.-based supplier of an active substance for the product, had deviated from good manufacturing practices at its Plainsboro, N.J., facility ().
Specifically, the inspectors noted that Integra did not have adequate measures in place to prevent particle contamination of the sponges. In the wake of this determination, the EMA’s Committee for Medicinal Products for Human Use asked Medtronic BioPharma, which is based in the Netherlands, how the findings from the April inspection of the Integra facility affect the risk-benefit balance of InductOs. The implant kit includes a powder that contains dibotermin alfa, a solvent, as well as an absorbable collagen sponge, an excipient.
The EMA has withdrawn the GMP certificate at the Integra plant.
While acknowledging that there is no indication of risk to patients linked to the inspection findings, the CHMP determined that the quality of InductOs cannot be assured with the current manufacturing process.
It concluded that InductOs should be suspended until the issues are satisfactorily addressed. In the meantime, there are alternative treatments available for patients, according to the health regulator.
The EMA’s recommendation will be sent to the European Commission for a final decision.
A Medtronic spokesman says the company is in regular contact with Integra and is working with the company on a remediation plan. Once the GMP certificate for the manufacturer is reissued, InductOs’ license will be restored.
The spokesman adds that Medtronic expects the facility will “be up and running soon.” The decision only affects the distribution of InductOs in Europe. — Elizabeth Hollis