Medtronic received FDA clearance for a new indication with its Infuse Bone Graft.
Here are five things to know.
1. The FDA approved Infuse, Medtronic's rhBMP-2 product, for use with spinal implants made from polyetheretherketone in oblique lateral interbody fusions and anterior lumbar interbody fusions at a single level.
2. The new approvals for Infuse include use with:
• OLIF 51 procedures with Divergence-L Interbody Fusion Device at a single level from L5-S1
• OLIF 25 procedures with Pivox Oblique Lateral Spine System at a single level from L2-L5
• ALIF procedures with Divergence-L at a single level from L2-S1
3. During surgery, Infuse is applied to an absorbable collagen sponge to deliver rhBMP-2 to the implant site. The material also acts as a scaffold for new bone formation and is designed to resorb over time.
4. The most recent indication is Medtronic's second expanded indication for Infuse in the past two years.
"This latest approval addresses some fairly common degenerative spine surgical correction needs," said Richard Hynes, MD, president of the B.A.C.K Center in Melbourne, Fla.