Accelus has has announced that more than 15,000 FlareHawk multiplanar expandable cages have been implanted in more than 11,000 patients in the USA.
Robert Norton, a spine surgeon from Boca Raton, USA, said: “FlareHawk is unique in its ability to insert in a very small size before expanding in height, width and lordosis within the disc space. This small initial insertion size allows for less potential nerve root irritation during insertion compared to other, larger interbody cages.
“The increased surface area after expansion and its large anterior column structural support help facilitate fusion. Because of the porosity of the cage, FlareHawk also allows for dispersion of the bone graft circumferentially around the cage, providing maximised post-pack bone graft delivery within the disc space.”
The FlareHawk portfolio of expandable lumbar fusion devices includes FlareHawk9, FlareHawk7 and the titanium-coated TiHawk7, TiHawk9 and TiHawk11 cages. FlareHawk cages all feature Accelus’s Adaptive Geometry, which allows the devices to be inserted with a minimal insertion profile before expanding in width, height and lordosis. This controlled, in situ multiplanar expansion is designed to restore foraminal height, re-establish sagittal balance and help reduce implant subsidence, say the company.
Chris Walsh, co-founder and chief executive officer of Accelus, added: “I’m incredibly proud to have hit this milestone with FlareHawk, and the fact that it is supported by an evidence-based, multicentre, peer-reviewed, published study demonstrating 97% fusion.”
A published study substantiating the safety and efficacy of FlareHawk by Dom Coric (Carolina Neurosurgery & Spine Associates, SpineFirst, Charlotte, USA) et al, demonstrated that nearly all patients (56 of 58 [96.6%]) and levels (75 of 77 [97.4%]) achieved fusion based on Bridwell-Lenke classification. Additionally, there were no reported device-related adverse events with no reported nerve injuries, no observations of cage subsidence (defined as an overlap between the vertebral endplates and the device exceeding 25% of device height), no reported endplate fractures, and one case (1.7%) of observed device migration.1
“FlareHawk was an evolution in interbody spacer design. I have been impressed with the lack of complications, as well as the high fusion rates and positive patient-reported outcomes associated with its use in my patient population,” said Coric.
A second study led by Boyle Cheng of Drexel University (Philadelphia, USA) showed 18 of 18 devices (100%) fused based on demonstrated bone growth evidence (average volume of 586.42mm3) and Bridwell-Lenke classification. This study also showed that FlareHawk’s unique combination of compliant and rigid components has the potential to conform to the interbody space obliquely, sagittally and coronally while maintaining sufficient stability to achieve fusion.2
FlareHawk received US Food and Drug Administration (FDA) 510(k) clearance in August 2016 and CE mark certification in April 2021. It is currently approved in 19 countries worldwide.
1. Coric D, Roybal RR, Grubb M, Rossi V, Yu AK, Swink IR, Long J, Cheng BC, Inzana JA. Bidirectional Expandable Technology for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Analysis of Safety and Performance. Int J Spine Surg. 2020 Dec;14(s3):S22-S30. doi: 10.14444/7123. Epub 2020 Oct 29. PMID: 33122186; PMCID: PMC7735440.
2. Cheng BC, Swink I, Yusufbekov R, Birgelen M, Ferrara L, Coric D. Current Concepts of Contemporary Expandable Lumbar Interbody Fusion Cage Designs, Part 2: Feasibility Assessment of an Endplate Conforming Bidirectional Expandable Interbody Cage. Int J Spine Surg. 2020 Dec;14(s3):S68-S74. doi: 10.14444/7129. Epub 2020 Oct 29. PMID: 33122178; PMCID: PMC7735472.