Accelus, a privately held medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in spine, today announced that more than 15,000 FlareHawk® multiplanar expandable cages have been implanted in more than 11,000 patients in the United States.
“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,” said Dr. Robert Norton. “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 maximized 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 innovative 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, reestablish sagittal balance and help reduce implant subsidence.
“I’m incredibly proud to have hit this milestone with FlareHawk, and the fact that it is supported by an evidence-based, multicenter, peer-reviewed, published study demonstrating 97% fusion,” said Chris Walsh, Co-Founder and Chief Executive Officer of Accelus.
A published study substantiating the safety and efficacy of FlareHawk by Dr. Dom Coric et al. demonstrated that nearly all patients (56 of 58, or 96.6%) and levels (75 of 77, or 97.4%) achieved fusion based on Bridwell-Lenke classification. Additionally, there were no (0%) reported device-related adverse events with no (0%) reported nerve injuries, no (0%) observations of cage subsidence (defined as an overlap between the vertebral endplates and the device exceeding 25% of device height), no (0%) 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 Dr. Coric, neurosurgeon at Carolina Neurosurgery and Spine Associates.
A second study led by Boyle Cheng, Ph.D., 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 FDA 510(k) clearance in August 2016 and CE mark certification in April 2021. It is currently approved in 19 countries worldwide.