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Reimbursement / Regulatory

FDA Approves Medtronic's INFUSE Bone Graft for New Spine Indications -

FDA has approved additional spine surgery indications for Medtronic's Infuse® Bone Graft, supporting use with certain PEEK implants in oblique lateral and anterior lumbar interbody fusion. 

The expanded approvals support marketing of Infuse for use with certain spine implants made of polyetheretherketone (PEEK) in oblique lateral interbody fusion (OLIF) and anterior lumbar interbody fusion (ALIF). Upon final labeling approval from FDA, Medtronic expects to begin marketing these expanded indications in early 2016. 

The new indications for Infuse relate to use in:

  • OLIF51™ with certain sizes of the PEEK Perimeter® implant at a single level from L5-S1
  • OLIF25™ with certain sizes of the PEEK Clydesdale® implant at a single level from L2-L5
  • ALIF with certain sizes of PEEK Perimeter at a single level from L2-S1

 

Infuse received its initial FDA approval in 2002; it is FDA-approved for certain spine, oral-maxillofacial and orthopaedic trauma surgeries. Its active ingredient, recombinant human bone morphogenetic protein-2 (rhBMP-2), is a manufactured protein that is applied to an absorbable collagen sponge and delivered to the surgical site, where it acts as a scaffold to form new bone. Its use eliminates the need to harvest patient bone in a second procedure.

Sources: Medtronic plc; FDA.gov Premarket Approval

 

Study results published within 4Q15 investigated use of rhBMP in spinal fusion, finding high rates of successful fusion at 1 year, no increased prevalence of any one type of cancer and low rates of other rhBMP-related complications, such as ectopic bone growth.

In its FY2Q16 conference call, Medtronic leadership noted that ex-U.S. BMP sales were impacted by a stop-shipment in EU. This activity was limited to a third-party manufacturing facility that only supplies the EU market and will be offline for the rest of Medtronic's fiscal year, reducing ex-U.S. BMP revenue by ~$7MM per quarter.

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