Europe’s medicines regulator has recommended the suspension of Medtronic Plc’s InductOs, an implant to help bone development, pending the resolution of issues at a U.S. plant where a sponge used in the implant is made.
The European Medicines Agency (EMA) said it began a review of InductOs after an inspection in April by Dutch and Spanish authorities of a site that makes an absorbable collage sponge.
The EMA said on Friday that the manufacturer did not comply with its requirements because it lacks adequate measures to prevent particle contamination of the sponges.
Medtronic said the agency had withdrawn a Good Manufacturing Practices certificate – mandatory for product licences in Europe from a plant operated by a third-party manufacturer.
The company, which is headquartered in Ireland, said it was working with the manufacturer to address the EMA’s concerns and that it expected the plant to be “up and running soon”.
“There is no risk to patients due to this manufacturing issue,” Medtronic said in a statement emailed to Reuters. “Existing supplies of InductOs in the market are safe for use.”
InductOs, used to help new bone develop in patients with spinal disc problems and leg fractures, was approved by the European Commission in September 2002 for use in the treatment of acute tibia fractures in adults.
It was approved for spinal disc problems in April 2005.
The EMA said there was no indication of any risk to patients linked to the inspection’s findings, but that its Committee for Medicinal Products for Human Use considered that the quality of InductOs could not be assured under the current manufacturing process.
Medtronic’s shares suffered no negative impact. They were up about 1 percent at $73.85 on the New York Stock Exchange. (Reporting by Roshni Menon and Mamidipudi Soumithri in Bengaluru; Editing by Robin Paxton)