The European Medicines Agency (EMA) has announced that it is recommending halting the sale of Medtronic's Inductos product. In the United States, the product is marketed as the Infuse Bone Graft, which has been the target of extensive litigation involving more than 1000 patients. An Infuse lawsuit may potentially be headed to the Supreme Court.
European regulators have decided to recommend halting sales of the Medtronic Inductos product citing manufacturing problems related to an absorbable sponge used in the product. The EMA began a review of the product after an inspection by Dutch and Spanish regulatory authorities determined that the U.S. manufacturing facility of the product did not comply with manufacturing requirements, and that the product could be afflicted with particle contamination.
The regulators were apparently concerned about the risk of potential contamination of the absorbable collagen sponge (ACS) component of the device after the visit to the U.S. facility. This component augments retention of rhBMP-2, an active biologic that induces bone formation, to the site of implantation. Although the regulatory agency states that there "is no indication of risk to patients linked to the inspection findings," it adds that the quality of the product cannot be guaranteed with the current manufacturing process.
The U.S. lawsuits largely center on the use of the Infuse product, which was developed in a 2002 collaborative effort between Integra Life Sciences, Medtronic, and Genetic Institute (Wyeth/Pfizer). The lawsuits allege that the product was used extensively in off-label spinal procedures that were not approved by the FDA.
The off-label use allegations largely relate to the use of Infuse product in combination with spinal cages that were not approved to be used with the biologic and cases where the product was used without any spinal cage, which are designed to contain the bone growth. Uncontrolled bone growth is the result of not being able to contain the primary mode of action (PMOA) of the biologic to the implant site, which can result in bony overgrowth causing compression of the spinal cord or surrounding nerve roots.
The collagen sponge component of Inductos and Infuse is manufactured and supplied by Integra Life Science under a licensing agreement with Medtronic.
Although the EMA withdrew a good manufacturing practices certificate for the facility that produces the Inductos sponge, Medtronic is working with the component maker to address the concerns. Medtronic notes that the problem only affects products distributed in Europe.
A report from Reuters states that the company expects the manufacturing to be "up and running soon."