Europe’s medical device regulator has recommended the suspension of marketing authorization for Medtronic’s InductOs, an implant to help bone development, pending the resolution of issues at a U.S. plant where a component of the implant is made.
The European Medicines Agency (EMA) began a review of InductOs (sold in the U.S. under the name InFuse) after an inspection in April by Dutch and Spanish authorities of a site that makes an absorbable collagen sponge that is part of the device, Reuters reports.
Earlier this month, the EMA said the manufacturer did not comply with its requirements because it had not taken adequate measures to prevent particle contamination of the sponges. According to Medtronic, the EMA withdrew a Good Manufacturing Practices certificate, which is mandatory for product licenses in Europe, from a plant operated by a third-party manufacturer. Medtronic, which is headquartered in Ireland, said it was working with the manufacturer to address the EMA’s concerns and said it expected the plant to be “up and running soon,” according to Reuters.
“There is no risk to patients due to this manufacturing issue,” Medtronic said in a statement that Reuters received by email. “Existing supplies of InductOs in the market are safe for use.”
InductOs is used to help new bone develop in patients with spinal disc problems and leg fractures. The device received approval from the European Commission in September 2002 for use in the treatment of acute tibia fractures in adults and approval for spinal disc problems in April 2005.
InductOs is sold as a kit containing its active ingredient dibotermin alfa, a solvent and an absorbable collagen sponge (ACS). The EMA has classified the ACS as an excipient of InductOs, and it is thus subject to inspection under EU good manufacturing practice (GMP) guidelines, according to RAPS (Regulatory Affairs Professionals Society).
The ACS included in the InductOs is manufactured by Integra LifeSciences at a plant in the U.S. A January 2014 inspection of Integra’s site uncovered “a number of major deficiencies.” Integra was given a corrective action plan and was restricted from importing the ACS to the EU, until inspectors could return to “assess the progress in eliminating the major deficiencies.” When inspectors returned to conduct their follow-up inspection in April 2015, they found Integra had not taken adequate steps to eliminate “contamination of ACS with particulate matter,” according to RAPS.
The EMA said there was no indication of any risk to patients linked to the inspection’s findings, but the agency said its Committee for Medicinal Products for Human Use considered that the quality of InductOs could not be assured under the current manufacturing process.