(Minnesota is not among the states investigating.) The company continues to cooperate with ongoing investigations into the sales and marketing of Infuse by attorneys general in five states, the Monday filing with the Securities and Exchange Commission said. 1, Medtronic reached agreements to settle about 3,900 of the cases for an undisclosed sum, according to securities filings published Monday. Used in more than 1 million people worldwide since 2002, Infuse is Medtronic’s largest product liability headache, accounting for more than 6,000 actual and threatened personal-injury lawsuits. In January the FDA advised doctors to avoid using rhBMP-2 in patients under 18 because their bones may still be growing. for spine surgeries that approach from the back, and the FDA has said rhBMP-2 may cause life-threatening complications if used to fuse bones in the neck. Infuse has never been approved in the U.S. Medtronic said in a news release that the FDA clearance gives doctors three more FDA-approved procedures - for surgery from a frontal approach using a PEEK implant to fuse two of five bones in the lower back and two other fusion procedures involving the same bones and PEEK implants, but where the doctor uses a surgical approach from the side of the body. Previously the bone-forming biologic was only approved for spinal-fusion surgery if it was placed inside a hollow titanium “cage” in the spine bone the new approval allows Medtronic to market Infuse inside of implants made of PEEK, a common plastic used in medical devices. Infuse’s active ingredient is a synthetic human protein called rhBMP-2 that causes bones to grow together after surgery. ![]() The Minnesota-run device company studied the published reports of those experiments and, based on the results, convinced the Food and Drug Administration to approve three new Infuse uses as safe, a company spokesman said Monday. regulators have cleared Medtronic’s controversial Infuse Bone Graft biologic product for lower-back surgery for use with plastic - rather than titanium - spinal components.ĭoctors have long legally used Infuse on their patients in ways not approved by U.S.
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