FlareHawk System from Accelus Gains Regulatory Approval in Brazil

Accelus has received regulatory approval in Brazil for its FlareHawk Interbody Fusion System. This milestone, granted by the Brazilian Health Regulatory Agency (ANVISA), includes FlareHawk7 and FlareHawk9 implant devices, reaffirming Accelus’s commitment to extend FlareHawk’s global availability.

The FlareHawk Interbody Fusion System 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.

“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.”

FlareHawk7 and FlareHawk9’s expanding footprint enables an 11mm- or 14 mm-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 with no additional retraction. 

The multi-material construct of the cage has been shown to conform to each patient’s endplate topography¹, potentially reducing the risk of subsidence. It has an open architecture design that 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.

“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.”

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. 

introducing Accelus’s FlareHawk Interbody Fusion System into this market is timely, aligning with the country’s increasing focus on surgeries that promise shorter recovery times, reduced postoperative pain, and minimal tissue disruption.

Reference:

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.