Integrity Implants announced study results that demonstrate fusion efficacy of the FlareHawk® expandable interbody device, without the use of processed biologics. Further, there were no observed reports of device subsidence, and the study set provides confirmation of the cage’s ability to conform to patients’ endplate geometry.
A lumbar Interbody fusion study followed strict inclusion criteria, including the allowance of only allograft and/or autograft to facilitate fusion. Participants represented patients with noteworthy comorbidities. Among subjects with radiographs at 12 ± 3 months, nearly all achieved fusion based on Bridwell-Lenke grading. There were no observations of cage subsidence, and only one case (1.7%) of observed device migration, and the patient went on to fuse.
Surgeon participants noted that FlareHawk allowed for a transition of cases to an outpatient, and an ability to treat patients via a single-position, posterior surgery.
A second, two-part study assessed the feasibility of a bidirectional, expandable interbody cage to achieve interbody fusion and and addressed aspects of the FlareHawk device: its multimaterial, open-architecture design that provides a combined spring effect for a modulus of elasticity similar to that of bone while maintaining sufficient support and stiffness from the titanium shim, and implant geometry that allows for the naturally occurring deformation of the PEEK shell to conform to each patient’s endplate configuration.
In the study, all 18 devices were determined to have fused based on demonstrated bone growth evidence and Bridwell-Lenke classification. The surgeon observed that the cage appears to conform in shape obliquely, sagittally and coronally, resulting in adaptive implant geometry. Additionally, the lack of endplate violation suggests that the FlareHawk cage is an atraumatic implant.
FlareHawk 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. Adaptive Geometry™ and a multimaterial composition accommodate patient anatomy both during insertion and for long-term stability.
To date, ~8,500 FlareHawk cages have been implanted in more than 6,000 patients. The initial FlareHawk system gained FDA 510(k) market clearance in 2019, with three subsequent clearances granted through 2020.
Chris Walsh, Integrity Implants CEO, shares, “The data suggests that the FlareHawk cage changes the PLIF/TLIF algorithm, enabling a single-position, reproducible, facility-friendly interbody solution that can provide surgeons significant efficiencies and latitude for their practices."