EU drugs agency recommends suspension of Medtronic implant
Europe’s medicines regulator recommended the suspension of Medtronic Plc’s Inductos, an implant used to help bone development, pending the resolution of issues at a U.S. site where a component is made.
The European Medicines Agency (EMA) began a review of Inductos following an inspection by Dutch and Spanish authorities of a site that makes an absorbable sponge used in the implant.
It said on Friday that the manufacturer did not comply with its requirements because it lacks adequate measures to prevent particle contamination of the sponges.
Although there is no indication of any risk to patients linked to the inspection’s findings, the regulator’s Committee for Medicinal Products for Human Use considers that the quality of Inductos cannot be assured under the current manufacturing process, the EMA said. (bit.ly/1kzdily)
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.
Medtronic, which is headquartered in Ireland, was not immediately available for comment
(Reporting by Roshni Menon in Bengaluru; Editing by Robin Paxton)
Source: Reuters Health