Medtronic (NYSE:MDT) said today that the FDA expanded the indication for its controversial InFuse bone-growth protein, allowing for its use with polyetheretherketone implants in oblique lateral interbody fusion and anterior lumbar interbody fusion surgeries.
The new indications cover single-level fusion OLIF51 procedures from the L5 vertebra to S1 with Medtronic’s PEEK Perimeter implant; OLIF25 fusions from L2 to L5 using the PEEK Clydesdale implant; and ALIF procedures from L2 to S1 using the Perimeter device, the company said.
InFuse caused a furor in 2008 over concerns that its sales were driven primarily by active promotion of off-label uses. Medtronic weathered a spate of lawsuits and an unprecedented Spine Journal issue in 2011 dedicated solely to concerns about its safety. The U.S. Justice Dept. and the U.S. Senate conducted probes into the bone morphogenetic compound and its Fridley, Minn.-based maker’s marketing practices, but in the end an independent study found that InFuse is equivalent to iliac crest bone grafts. The study also found that Medtronic-sponsored trials of the Infuse rhBMP-2 product were biased. Last year the company inked a $22 million deal to settle about 950 InFuse lawsuits.
“We believe in the safety and effectiveness of Infuse bone graft and reiterate our continued commitment to the product,” spinal business president Doug King said in prepared remarks. “With these expanded indications, we can bring the benefits of this important technology to more patients to help ensure they achieve a solid fusion and the best potential for a positive clinical outcome.”
InFuse is also cleared for some spinal, oral-maxillofacial and orthopedic trauma surgeries, Medtronic said.
“For my anterior and anterolateral lumbar spine fusion cases, the use of Infuse bone graft allows me to reliably obtain a solid arthrodesis without having to harvest bone from the patient’s own hip, which generally requires a 2nd incision, results in significant pain, and increases the risk of complications such as bleeding or infection,” added Dr. Peter Whang of the Yale School of Medicine. “In particular, I believe that the proven osteoinductive properties of Infuse bone graft are particularly beneficial when used in conjunction with PEEK interbody spacers and the less invasive OLIF technique, which circumvents the psoas muscle and minimizes disruption of the surrounding soft tissues and neural structures.”