PALM BEACH GARDENS, Fla., Oct. 11, 2022 (GLOBE NEWSWIRE) — Accelus, a privately held medical expertise firm centered on accelerating the adoption of minimally invasive surgical procedure (MIS) as the usual of care in spine, at this time 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 skill to insert in a really small measurement earlier than increasing in peak, width and lordosis inside the disc area. This small preliminary insertion measurement permits for much less potential nerve root irritation throughout insertion in comparison with different, bigger interbody cages,” stated Dr. Robert Norton. “The elevated floor space after enlargement and its giant anterior column structural assist 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 area.”
The FlareHawk portfolio of expandable lumbar fusion gadgets contains FlareHawk9, FlareHawk7 and the titanium-coated TiHawk7, TiHawk9 and TiHawk11 cages. FlareHawk cages all function Accelus’s progressive Adaptive Geometry™, which permits the gadgets 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 steadiness and assist scale 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,” stated Chris Walsh, Co-Founder and Chief Government Officer of Accelus.
A broadcast 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 adversarial occasions with no (0%) reported nerve accidents, no (0%) observations of cage subsidence (outlined as an overlap between the vertebral endplates and the gadget exceeding 25% of gadget peak), no (0%) reported endplate fractures, and one case (1.7%) of noticed gadget migration.1
“FlareHawk was an evolution in interbody spacer design. I’ve been impressed with the shortage of problems, in addition to the excessive fusion charges and constructive patient-reported outcomes related to its use in my affected person inhabitants,” stated Dr. Coric, neurosurgeon at Carolina Neurosurgery and Backbone Associates.
A second research led by Boyle Cheng, Ph.D., confirmed 18 of 18 gadgets (100%) fused primarily based on demonstrated bone progress 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 evolve to the interbody area obliquely, sagittally and coronally whereas sustaining adequate stability to realize fusion.2
FlareHawk acquired FDA 510(okay) clearance in August 2016 and CE mark certification in April 2021. It’s at present accepted in 19 international locations worldwide.
Accelus is dedicated to accelerating minimally invasive spine surgical procedure via its enabling expertise with broad accessibility to beforehand underserved markets. Established in 2021 via the mixture of Integrity Implants and Fusion Robotics, the corporate is concentrated on offering its proprietary Adaptive Geometry™ expertise with pragmatic and economical navigation and robotic options with broad medical use in spine surgical procedure. Be taught extra at www.accelusinc.com.
Media Contact: Brandy Craig
1. Coric D, Roybal RR, Grubb M, Rossi V, Yu AK, Swink IR, Lengthy J, Cheng BC, Inzana JA. Bidirectional Expandable Know-how for Transforaminal or Posterior Lumbar Interbody Fusion: A Retrospective Evaluation of Security and Efficiency. Int J Backbone 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. Present Ideas of Modern Expandable Lumbar Interbody Fusion Cage Designs, Half 2: Feasibility Evaluation of an Endplate Conforming Bidirectional Expandable Interbody Cage. Int J Backbone Surg. 2020 Dec;14(s3):S68-S74. doi: 10.14444/7129. Epub 2020 Oct 29. PMID: 33122178; PMCID: PMC7735472.
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