PALM BEACH GARDENS, Fla., Feb. 11, 2025 – Accelus, a privately held medical technology company committed to becoming the global market leader in expandable spinal implant technologies, today announced that its innovative FlareHawk® Interbody Fusion System has received regulatory approval in Brazil. This significant milestone, granted by the Brazilian Health Regulatory Agency (ANVISA), includes both FlareHawk7™ and FlareHawk9™ implant devices, reaffirming Accelus’s unwavering commitment to extend FlareHawk’s global availability.
“We are excited about our recent ANVISA approval to market both our FlareHawk7 and FlareHawk9 implants in Brazil, marking another step toward delivering cutting-edge spinal solutions worldwide,” said Kevin McGann, President and CEO of Accelus. “This approval highlights our commitment to meeting the needs of spine surgeons globally and ensuring more patients can benefit from our innovative solutions designed to elevate the surgeon experience and outcomes.”
The FlareHawk Interbody Fusion System, with more than 22,000 devices implanted in 24 countries worldwide, represents a significant advancement in spinal interbody fusion. It utilizes Accelus’s proprietary Adaptive Geometry™ technology to expand in width, height and lordosis after insertion with a minimal profile. FlareHawk’s multi-directional expansion is designed to reduce subsidence, restore foraminal height and reestablish sagittal balance from a posterior approach.
FlareHawk7 and FlareHawk9’s expanding footprint enables an 11mm- or 14mm-wide implant to be inserted using the same retraction required for a 7mm or 9mm implant (respectively), providing up to a 57% increase in width without the need for additional retraction. The multi-material construct of the cage has been shown to conform to each patient’s endplate topography1, potentially further reducing the risk of subsidence. Its open architecture design also facilitates continuous graft delivery in and through the implant into the disc space, providing up to 1.6cm² of bone-graft-to-endplate total contact area.
Brazil represents a vital and growing market for minimally invasive spine surgery, where the demand for advanced surgical techniques and innovative medical devices is rising. The introduction of Accelus’s FlareHawk Interbody Fusion System into this dynamic market is timely, aligning with the country’s increasing focus on surgeries that promise shorter recovery times, reduced postoperative pain, and minimal tissue disruption. FlareHawk’s unique Adaptive Geometry™ technology provides a minimal insertion profile with maximum multidirectional interbody expansion. This feature, combined with the product’s excellent clinical outcomes, positions FlareHawk as a well-suited solution for the evolving needs of Brazil’s spine surgery sector.
“We are immensely proud of the recent regulatory approval for the FlareHawk Interbody Fusion System in Brazil,” said Jose Calleja, Executive Vice President of International at Accelus. “This achievement is not just a milestone for Accelus but also a reflection of our synergistic collaboration with our exclusive distributor in Brazil, Otima, whose invaluable local expertise and commitment have been crucial in navigating the Brazilian regulatory landscape and bringing our innovative spinal solutions to this important market.”
About Accelus
Accelus, a worldwide leader in expandable spinal implant technology, is dedicated to enhancing surgical procedures and patient outcomes through innovative spinal solutions. The company’s commitment to excellence is evident in its advanced Adaptive Geometry™ technologies specifically designed for transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF), endoscopic-assisted, percutaneous, and lateral spine surgeries. For more information on Accelus and its innovative product portfolio, please visit www.accelusinc.com.
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1. Cheng BC, Swink I, Yusufbekov R, Birgelen Michele, 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. International Journal of Spine Surgery. https://www.ijssurgery.com/content/14/s3/S68. Published December 1, 2020.
