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Medical equipment industry

Medtronic's InductOs Receives EU Approval for Spinal Fusion Indication

Strategic Insights

— 1 min read

The European Commission has granted approval for Medtronic Inc.'s (MDT) InductOs to be used in spinal fusion procedures for adults with degenerative disc disease. InductOs contains rhBMP-2, a protein that promotes new bone growth, reducing the need for bone harvesting from the patient's hip. This indication is in addition to its original approval in 2002 for the treatment of acute tibia fractures. With the approval, InductOs is now available for single-level anterior lumbar spinal fusion in adults with degenerative disc disease who have had at least six months of non-operative treatment.

Key Takeaways:

  • InductOs is a surgically implanted product containing recombinant human bone morphogenetic protein (rhBMP-2) that promotes new bone growth.
  • The product is now approved for use in spinal fusion procedures for adults with degenerative disc disease.
  • The procedure eliminates the need for bone harvesting from the patient's hip, reducing complications and pain.
  • Degenerative disc disease affects approximately half of the population aged 40 and older.
  • InductOs was originally approved in 2002 for the treatment of acute tibia fractures, and it has been used safely and effectively in treating tens of thousands of patients in the United States.
  • RhBMP-2 has been used to treat patients with lumbar degenerative disc disease in the US, where the product is known as INFUSE Bone Graft.
  • Medtronic's biopharmaceutical facility in Andover, Massachusetts, manufactures the protein.
  • Medtronic Sofamor Danek is the company's spinal business, committed to advancing the treatment of spinal disorders.
  • The diabetes business unit of Medtronic Inc. announced FDA clearance of expanded labeling for its external model 407C general medication infusion pump.

Statistics:

  • Approximately half of the population aged 40 and older suffers from degenerative disc disease.
  • Tens of thousands of patients have been treated with INFUSE Bone Graft in the US.
  • 6 months of non-operative treatment is recommended for adults with degenerative disc disease before considering spinal fusion.
  • 2002: The year InductOs was originally approved for the treatment of acute tibia fractures.

Sources:

  • Medtronic Inc.
  • European Commission
  • Health & Medicine Week
  • NewsRx.com

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