Accelus Pronounces New Milestone With Its FlareHawk ® Interbody Fusion System Surpassing 15,000 Gadgets Implanted
Accelus, a privately held medical know-how firm centered on accelerating the adoption of minimally invasive surgical procedure (MIS) as the usual of care in backbone, at the moment introduced that greater than 15,000 FlareHawk® multiplanar expandable cages have been implanted in additional than 11,000 sufferers in america.
“FlareHawk is exclusive in its capability to insert in a really small dimension earlier than increasing in peak, width and lordosis inside the disc house. This small preliminary insertion dimension permits for much less potential nerve root irritation throughout insertion in comparison with different, bigger interbody cages,” mentioned Dr. Robert Norton. “The elevated floor space after enlargement and its giant anterior column structural help assist facilitate fusion. Due to the porosity of the cage, FlareHawk additionally permits for dispersion of the bone graft circumferentially across the cage, offering maximized post-pack bone graft supply inside the disc house.”
The FlareHawk portfolio of expandable lumbar fusion units contains FlareHawk9, FlareHawk7 and the titanium-coated TiHawk7, TiHawk9 and TiHawk11 cages. FlareHawk cages all function Accelus’s progressive Adaptive Geometry™, which permits the units to be inserted with a minimal insertion profile earlier than increasing in width, peak and lordosis. This managed, in situ multiplanar enlargement is designed to revive foraminal peak, reestablish sagittal stability and assist cut back implant subsidence.
“I’m extremely proud to have hit this milestone with FlareHawk, and the truth that it’s supported by an evidence-based, multicenter, peer-reviewed, revealed research demonstrating 97% fusion,” mentioned Chris Walsh, Co-Founder and Chief Government Officer of Accelus.
A printed research substantiating the security and efficacy of FlareHawk by Dr. Dom Coric et al. demonstrated that almost all sufferers (56 of 58, or 96.6%) and ranges (75 of 77, or 97.4%) achieved fusion primarily based on Bridwell-Lenke classification. Moreover, there have been no (0%) reported device-related hostile occasions with no (0%) reported nerve accidents, no (0%) observations of cage subsidence (outlined as an overlap between the vertebral endplates and the machine exceeding 25% of machine peak), no (0%) reported endplate fractures, and one case (1.7%) of noticed machine migration.1
“FlareHawk was an evolution in interbody spacer design. I’ve been impressed with the dearth of issues, in addition to the excessive fusion charges and optimistic patient-reported outcomes related to its use in my affected person inhabitants,” mentioned Dr. Coric, neurosurgeon at Carolina Neurosurgery and Backbone Associates.
A second research led by Boyle Cheng, Ph.D., confirmed 18 of 18 units (100%) fused primarily based on demonstrated bone development proof (common quantity of 586.42mm3) and Bridwell-Lenke classification. This research additionally confirmed that FlareHawk’s distinctive mixture of compliant and inflexible elements has the potential to adapt to the interbody house obliquely, sagittally and coronally whereas sustaining enough stability to attain fusion.2
FlareHawk acquired FDA 510(okay) clearance in August 2016 and CE mark certification in April 2021. It’s at the moment authorised in 19 nations worldwide.