Contamination Problems Prompt EMA to Review Medtronic's InductOsJul 31, 2015
Contamination issues have prompted the European Medicines Agency (EMA) to conduct a review of Medtronic's InductOs, an implantable bone-development product. Regulatory Affairs Professionals Society reports that Spanish and Dutch inspectors found problems with contamination at a manufacturing site that makes one of the devices' components, and that these issues were not resolved upon a follow-up inspection.
InductOs, which is marketed by Medtronic BioPharma B.V., is used to help stimulate bone growth in patients undergoing spinal fusion in the lower back. It is also used in surgeries to repair broken tibia. The active ingredient in InductOs is dibotermin alfa; this is included in the kit the device is sold in, along with an absorbable collagen sponge (ACS). Integra LifeSciences manufactures the ACS included with InductOs. Inspectors who evaluated Integra's site in January 2014 found "a number of major deficiencies." according to RAPS. Integra was issued a corrective action plan in response to these findings. The company was prohibited from importing the ACS to the EU until inspectors could return to "assess the progress in eliminating the major deficiencies."
Apparently, the contamination issues were not resolved upon follow-up. Inspectors said Integra failed to eliminate "contamination of ACS with particulate matter" when they returned to the site in April 2015. In July, the Netherlands issued a draft statement of non-compliance. The European Commission (EC) and EMA's Committee for Medicinal Products for Human Use (CHMP) were also notified. The draft statement of non-compliance was finalized on July 23rd. The EC then asked the EMA to "assess the [issues] and their impact on the benefit risk balance for InductOs."
In light of the reported contamination issues, EMA will now start its review of InductOs and make recommendations for marketing authorization as needed, RAPS reports. In the meantime, the agency wants to ask Medtronic if there have been any "safety reports or complaints related to the contaminating particulate matter," and if there are "any patient population(s) for whom there is no other treatment option available." Additionally, EMA wants Medtronic to provide a timeline of action to "ensure that the manufacturing of the ACS will be GMP compliant."