FDA Green Lights Medtronic's Infuse Bone Graft in New Spine Surgery Indications
Two additional implants are added to the current spine labeling.
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."
