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Accelus received FDA 510(k) clearance for its FlareHawk Interbody Fusion System to be safely subjected to MRI scanning in certain conditions.
The clearance follows rigorous safety testing and modeling studies, which demonstrated that the FlareHawk implants meet established ASTM standards for MRI compatibility under certain scanning conditions. The testing evaluated magnetic field interactions, radiofrequency-induced heating, and image artifacts, establishing the safety of FlareHawk implants in various MRI environments.
Patients implanted with the FlareHawk Interbody Fusion System may be safely scanned under the conditions outlined in the FlareHawk Instructions for Use and at www.accelusinc.com/mrisafety.
FlareHawk implants are designed with a PEEK shell, a titanium surface technology embedded into the shell substrate and an internal titanium shim. These implants feature a small insertion profile that minimizes neural retraction during placement, followed by multidirectional expansion in height, width, and lordosis. This design is intended to reduce the risk of subsidence, restore foraminal height and re-establish sagittal balance.
To date, more than 32,000 FlareHawk cages have been implanted in 25 countries worldwide.
“The ability to confidently undergo MRI scans is an important factor for both patients and surgeons when selecting spinal implants,” said Kevin McGann, President and CEO of Accelus. “This additional clearance reinforces our commitment to offering safe, high-quality solutions that address the real-world needs of the spine surgery community.”
Source: Accelus
Accelus received FDA 510(k) clearance for its FlareHawk Interbody Fusion System to be safely subjected to MRI scanning in certain conditions.
The clearance follows rigorous safety testing and modeling studies, which demonstrated that the FlareHawk implants meet established ASTM standards for MRI compatibility under certain scanning conditions....
Accelus received FDA 510(k) clearance for its FlareHawk Interbody Fusion System to be safely subjected to MRI scanning in certain conditions.
The clearance follows rigorous safety testing and modeling studies, which demonstrated that the FlareHawk implants meet established ASTM standards for MRI compatibility under certain scanning conditions. The testing evaluated magnetic field interactions, radiofrequency-induced heating, and image artifacts, establishing the safety of FlareHawk implants in various MRI environments.
Patients implanted with the FlareHawk Interbody Fusion System may be safely scanned under the conditions outlined in the FlareHawk Instructions for Use and at www.accelusinc.com/mrisafety.
FlareHawk implants are designed with a PEEK shell, a titanium surface technology embedded into the shell substrate and an internal titanium shim. These implants feature a small insertion profile that minimizes neural retraction during placement, followed by multidirectional expansion in height, width, and lordosis. This design is intended to reduce the risk of subsidence, restore foraminal height and re-establish sagittal balance.
To date, more than 32,000 FlareHawk cages have been implanted in 25 countries worldwide.
“The ability to confidently undergo MRI scans is an important factor for both patients and surgeons when selecting spinal implants,” said Kevin McGann, President and CEO of Accelus. “This additional clearance reinforces our commitment to offering safe, high-quality solutions that address the real-world needs of the spine surgery community.”
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.
