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Accelus’ FlareHawk Interbody Fusion System received regulatory approval in Brazil. This milestone, granted by the Brazilian Health Regulatory Agency (ANVISA), includes both FlareHawk7 and FlareHawk9 implant devices.
The FlareHawk Interbody Fusion System utilizes Accelus’ 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 topography, 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.
“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.”
“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.”
Source: Accelus
Accelus' FlareHawk Interbody Fusion System received regulatory approval in Brazil. This milestone, granted by the Brazilian Health Regulatory Agency (ANVISA), includes both FlareHawk7 and FlareHawk9 implant devices.
The FlareHawk Interbody Fusion System utilizes Accelus’ proprietary Adaptive Geometry technology to expand in width, height and...
Accelus’ FlareHawk Interbody Fusion System received regulatory approval in Brazil. This milestone, granted by the Brazilian Health Regulatory Agency (ANVISA), includes both FlareHawk7 and FlareHawk9 implant devices.
The FlareHawk Interbody Fusion System utilizes Accelus’ 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 topography, 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.
“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.”
“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.”
Source: Accelus
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
