Panel’s Support May Help Case for Medtronic’s Amplify Matrix

Medtronic may have picked up some support for approval of its Amplify recombinant human bone morphogenetic protein-2 (rhBMP) matrix when a Centers for Medicare & Medicaid Services’ (CMS) panel voiced confidence in current on-label uses for rhBMPs. CMS’ Medicare Evidence Development & Coverage Advisory Committee met recently to weigh the evidence and benefits of approved and off-label uses of rhBMPs. Use of the proteins has grown rapidly since they became clinically available in 2001. However, up to 85 percent of that use is off-label, mostly in the spine, CMS says.
Devices & Diagnostics Letter