The Brazilian Health Regulatory Agency (ANVISA) granted approval for the FlareHawk7 and FlareHawk9 spine implant devices.
“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,” President and CEO Kevin McGann said in a news release. “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 uses Accelus’ Adaptive Geometry technology to expand in width, height and lordosis after insertion with a minimal profile. Accelus designed FlareHawk to reduce subsidence, restore foraminal height and reestablish sagittal balance from a posterior approach.
FlareHawk7 and FlareHawk9’s expanding footprint allows for an 11mm- or 14mm-wide implant to be inserted using the same retraction required for a 7mm or 9mm implant. The multi-material design of the cage can conform to each patient’s endplate topography, according to the company. The open architecture design also allows for continuous graft delivery in and through the implant into the disc space.
“We are immensely proud of the recent regulatory approval for the FlareHawk Interbody Fusion System in Brazil,” said Jose Calleja, executive VP 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.”
