Integrity Implants has announced positive data from a retrospective study demonstrating favourable fusion efficacy with its FlareHawk interbody implant. The study, ‘Transforaminal/posterior lumbar interbody fusion with the FlareHawk expandable interbody fusion device,’ was led by principal investigator Domagoj Coric, chief of neurosurgery at Carolinas Medical Center and Spine Division chief of Atrium Musculoskeletal Institute (Charlotte, USA).
Results from the multicentre study of 129 patients validate the safety and efficacy of the FlareHawk expandable fusion device, Integrity Implants said in a press release. Among 58 subjects with radiographs at 12±3 months, nearly all (56 patients, or 96.6%) achieved fusion based on Bridwell-Lenke grading. Among 45 evaluable subjects, 71% (32 patients) achieved clinically significant improvements in VAS leg pain, and 76% (34 patients) achieved clinically significant improvements in VAS back pain. Additionally, there were no reported device-related adverse events (AEs). Common device-related AEs associated with interbody fusion devices include, but are not limited to, subsidence, displacement, and nerve injury. The incidence rate for non-device related AEs was 14.7%, which is consistent with other TLIF/PLIF studies.
Coric said: “This study adds to the evidence base supporting the safe and effective use of expandable interbody spacers in the treatment of lumbar spine diseases. The FlareHawk implant’s ability to expand in both cephalad-caudal and lateral-medial planes is especially advantageous for decreasing neural retraction while maximising vertebral body endplate coverage and fusion area.”
The FlareHawk expandable cage features a PEEK shell that is inserted in a compressed form that can be effectively passed through small neural pathways and, once within the intervertebral disc space, expanded to a larger footprint and height. A titanium shim inserted within the PEEK shell produces the expansion and creates a solid-state construct that is resistant to collapse. The design accommodates the delivery of appropriate bone graft material into and through the apertures of the cage.
Chris Walsh, Integrity Implants CEO, said: “Importantly, this data set was achieved without the use of any biologics other than autogenous or allogenic bone graft, further validating our thesis that minimal nerve retraction and a large footprint are design imperatives that decrease the strain on a surgeon and facility to achieve a stable fusion. From the outset, we have heard anecdotally from our surgeon user group that the FlareHawk cage can be implanted with minimal or no nerve retraction and is a ‘fire and forget’ device, so we are thrilled, but not surprised, that the data set showed no device-related adverse events. With our TLIF and PLIF platforms complete, look for Integrity to expand our Adaptive Geometry platform into lateral, Kambin’s, and anterior approaches.”
The FlareHawk Interbody Fusion System is 510(k) cleared by the US Food and Drug Administration (FDA) and is indicated for spinal intervertebral body fusion with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy.