Business Wire09.29.21
Alphatec Holdings announced the launch of the InVictus OsseoScrew Expandable Spinal Fixation System.
InVictus OsseoScrew has been designed to be an alternative to the conventional use of cemented fenestrated screws for patients with compromised bone. The system is intended to restore spinal column integrity, even in the absence of fusion, in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. An expansion of the InVictus Posterior Fixation Platform, InVictus OsseoScrew integrates seamlessly with InVictus MIS and Open platforms as well as SafeOp™ Automated EMG.
“InVictus OsseoScrew advances care for patients with compromised bone quality; a testament of ATEC's pursuit of solutions for unmet clinical needs," said Pat Miles, Chairman and CEO. “The system enhances the versatility of InVictus, our industry-leading comprehensive posterior fixation system, and provides surgeons with greater optionality to customize patient care. InVictus OsseoScrew will align well with the level-specific bone density information that EOS will soon be capable of ascertaining, establishing a foundation for the next-generation of ATEC surgical planning.”
With a significant 29 percent increase in pull-out strength compared to standard pedicle screws1, OsseoScrew is engineered to address the clinical challenges of treating patients with compromised bone. In a randomized clinical study In Europe, patients with the system demonstrated clinical fusion and segment stability outcomes comparable to cemented fenestrated screws, while circumventing the risk of perivertebral cement leakage, a frequently occurring complication that can lead to severe complications.2 In the study, OsseoScrew demonstrated a statistically significant lower prevalence of adverse device events at 8 percent, compared to over 55 percent for cemented fenestrated screws.3
Christopher DeWald, MD, Assistant Professor and Director of the Spine Deformity Section of Rush University, commented, “InVictus OsseoScrew is a solution for an underserved patient population. The system allows the surgeon a controlled expansion to optimize fixation with improved screw purchase, while helping to minimize the clinical challenge of pedicle screw failure by pull out. It can be elegantly integrated with SafeOp to provide a more predictable technique and reinforce confidence during screw insertion.”
Key Features of InVictus Osseoscrew Expandable Spinal Fixation
References
1 Vishnubhotla S, McGarry WB, Mahar AT, et al. A titanium expandable pedicle screw improves initial pullout strength as compared with standard pedicle screws. Spine J 2011;11:777-81.
2 Zhang J, Wang G, Zhang N. A meta-analysis of complications associated with the use of cement-augmented pedicle screws in osteoporosis of spine. Orthop Traumatol Surg Res 2020 Dec 15:102791.
3 Data on file.
InVictus OsseoScrew has been designed to be an alternative to the conventional use of cemented fenestrated screws for patients with compromised bone. The system is intended to restore spinal column integrity, even in the absence of fusion, in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. An expansion of the InVictus Posterior Fixation Platform, InVictus OsseoScrew integrates seamlessly with InVictus MIS and Open platforms as well as SafeOp™ Automated EMG.
“InVictus OsseoScrew advances care for patients with compromised bone quality; a testament of ATEC's pursuit of solutions for unmet clinical needs," said Pat Miles, Chairman and CEO. “The system enhances the versatility of InVictus, our industry-leading comprehensive posterior fixation system, and provides surgeons with greater optionality to customize patient care. InVictus OsseoScrew will align well with the level-specific bone density information that EOS will soon be capable of ascertaining, establishing a foundation for the next-generation of ATEC surgical planning.”
With a significant 29 percent increase in pull-out strength compared to standard pedicle screws1, OsseoScrew is engineered to address the clinical challenges of treating patients with compromised bone. In a randomized clinical study In Europe, patients with the system demonstrated clinical fusion and segment stability outcomes comparable to cemented fenestrated screws, while circumventing the risk of perivertebral cement leakage, a frequently occurring complication that can lead to severe complications.2 In the study, OsseoScrew demonstrated a statistically significant lower prevalence of adverse device events at 8 percent, compared to over 55 percent for cemented fenestrated screws.3
Christopher DeWald, MD, Assistant Professor and Director of the Spine Deformity Section of Rush University, commented, “InVictus OsseoScrew is a solution for an underserved patient population. The system allows the surgeon a controlled expansion to optimize fixation with improved screw purchase, while helping to minimize the clinical challenge of pedicle screw failure by pull out. It can be elegantly integrated with SafeOp to provide a more predictable technique and reinforce confidence during screw insertion.”
Key Features of InVictus Osseoscrew Expandable Spinal Fixation
- Achieves 29 percent greater pull-out strength over conventional pedicle screws
- Designed to optimize pedicle fixation with expansion zone location
- Promotes stabilization in patients with compromised bone structures
References
1 Vishnubhotla S, McGarry WB, Mahar AT, et al. A titanium expandable pedicle screw improves initial pullout strength as compared with standard pedicle screws. Spine J 2011;11:777-81.
2 Zhang J, Wang G, Zhang N. A meta-analysis of complications associated with the use of cement-augmented pedicle screws in osteoporosis of spine. Orthop Traumatol Surg Res 2020 Dec 15:102791.
3 Data on file.