FDA Green Lights Medtronic's Infuse Bone Graft in New Spine Surgery Indications

Medtronic announced that the US Food and Drug Administration (FDA) approved Infuse™ Bone Graft in new spine surgery indications with additional spine implants made of polyetheretherketone (PEEK) in oblique lateral interbody fusion (OLIF 25™ and OLIF 51™) and anterior lumbar interbody fusion (ALIF) procedures at a single level.

The newly approved indications include use in OLIF 51 procedures with Divergence-L®Interbody Fusion Device at a single level from L5—S1; use in OLIF 25 procedures with Pivox Oblique Lateral Spine System at a single level from L2–L5; and use in ALIF procedures with Divergence-LInterbody Fusion Device at a single level from L2–S1.

“Different spine patients can have very different surgical needs, so the more options surgeons have to combine a clinically-proven bone grafting technology like Infuse with different procedures and implants, the greater the likelihood of successful outcomes,” Richard Hynes, MD, FACS, president and spine surgeon, B.A.C.K Center, said in a statement. “This latest approval addresses some fairly common degenerative spine surgical correction needs.”

The Infuse implant contains the active ingredient rhBMP—2, a manufactured version of a bone growth protein normally present in the body. In surgery, it’s applied to an absorbable collagen sponge, which is a carrier to deliver the rhBMP-2 to the implant site, acting as a scaffold for the formation of new bone — it then will resorb or disappear over time.

The device is designed for use with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease.

The Infuse/Medtronic Interbody Fusion Device consists of 2 components containing 3 parts — a spinal fusion cage, a recombinant human bone morphogenetic protein and a carrier/scaffold for the bone morphogenetic protein and resulting bone. The components must be used as a system.

Infuse Bone Graft is approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries. More than 1 million patients have used Infuse, as it has been on the market since 2002.

This is the second expanded indication in 2 years.

"Infuse Bone Graft remains one of the most-extensively studied products in spine that is commercially available today," Doug King, senior vice president and president, Medtronic's Spine division, said in a statement. "The expanded approval with these PEEK devices for OLIF25, OLIF51 and ALIF procedures provide important options for surgeons and their patients."