FDA Approves Infuse for Two More Spine Devices

The FDA has given Medtronic plc approval to use the company’s Infuse bone graft with two additional implants.

The approval is for 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 company stated in an April 30, 2018 press release that this was the second expanded indication for Infuse in just over two years.

The new approved indications for Infuse Bone Graft are:

• 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.
• Use in ALIF procedures with Divergence-L Interbody Fusion Device at a single level from L2-S1.

Richard Hynes, M.D., president of and spine surgeon at the B.A.C.K. Center in Melbourne, Florida, said this latest approval “addresses some fairly common degenerative spine surgical correction needs.”

“Infuse Bone Graft remains one of the most-extensively studied products in Spine that is commercially available today,” said Doug King, senior vice president and president of Medtronic’s Spine division.

King may have been referring to Medtronic’s work in 2011 with Yale University and the YODA (Yale University Open Data Access) Project to independently review its Infuse bone graft study information, with the company providing a $2.5 million grant to the school to complete two reviews of the safety and effectiveness information. The YODA Project used a data-sharing model to study and release all the company’s clinical research data related to rhBMP-2.

The extensive studies came after significant off-label use by surgeons prompted questions over the promotion of the product.

Infuse, according to the company, is approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries. The product has been on the market since 2002 and has been used in more than one million patients worldwide.

The active ingredient in Infuse Bone Graft is rhBMP-2 and is applied to an absorbable collagen sponge (ACS). The ACS is a carrier to deliver the rhBMP-2 to the implant site and acts as a scaffold for the formation of new bone, and it will resorb, or disappear, over time.

The Divergence-L Interbody Fusion Device and the Pivox Oblique Lateral Spine System incorporate the technology of Gary K. Michelson, M.D.

Last September, Medtronic announced that patient enrollment had begun for a prospective long-term 10-year multicenter study of Infuse among patients undergoing posterolateral fusion and transforaminal lumbar interbody fusion (TLIF).

Also, last September at the 52nd Annual Meeting of the Scoliosis Research Society, Medical Device Daily reported that William Blair analysts noted the company is increasing its investment in its biologics franchise and data behind Infuse, “which should support continued improvement in this business.” The analysts also reportedly said they heard the company plans to spend nearly $100 million to generate clinical support over the next several years.