Reducing Hardware in Spinal Fusion: Groundbreaking Published Biomechanical Cadaveric Study Validates FacetFuse® as Equivalent to Traditional Pedicle Screws — A Leap Forward
November 12, 2024
Barrow Neurological Institute Confirms Biomechanical Equivalence of FacetFuse to Conventional Pedicle Screws, Ushering a New Pathway for Outpatient LESS Exposure Spine Surgery (LESS)
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Fort Lauderdale, FL — A peer-reviewed scientific study published in the September 2024 issue of the Journal of Spine Surgery has confirmed that FacetFuse® transfacet pedicle screws provide biomechanical stability equivalent to traditional pedicle screws, marking a transformative advancement in LESS Exposure Spine Surgery. Conducted independently by PhDs at the renowned Barrow Neurological Institute, the study demonstrated that FacetFuse achieves comparable stability to conventional pedicle screw constructs. By using a streamlined, LESS Exposure approach that reduces hardware requirements, FacetFuse minimizes risks associated with adjacent segment degeneration (ASD) and avoids disruption to the multifidus muscles. This validation establishes FacetFuse as a pioneering solution in the evolving field of LESS Exposure Spine Surgery, offering a safer and faster option for patients in need of outpatient spinal fusion.
The LESS Exposure Philosophy: Transforming Spine Surgery
The LESS Exposure Spine Surgery philosophy, developed by Harvard-trained Orthopedic Spine Surgeon Professor Dr. Kingsley R. Chin, is centered on restoring and preserving spine anatomy through simplified, patient-focused techniques that reduce the complexity and inherent risks of traditional constructs. FacetFuse embodies these principles by using just two transfacet pedicle screws, placed mediolaterally away from the spinal canal, compressing the facets together for immediate stability. This approach eliminates the need for rods or set screws, preserving adjacent segment integrity. With over 12,000 FacetFuse implants performed globally, this study reaffirms FacetFuse’s unique capacity to stabilize the spine while optimizing patient outcomes.
Clinical Validation for FacetFuse: Surgeon and Physician Endorsements
"FacetFuse aligns perfectly with our LESS philosophy,” stated Dr. Erik Spayde, an orthopedic spine surgeon and Chief Spine Surgeon at a major hospital, who has successfully integrated FacetFuse into his outpatient spine practice. “This solution provides stable, effective fusions without the extensive hardware and longer operative times of traditional methods.” Dr. William Costigan, Chief of Spine Surgery at a major hospital, added, “FacetFuse has been transformative for a broad range of patients needing spine fusion, especially those who benefit from a simpler, less invasive option without the complexity of traditional pedicle screw-rod systems.”
Expanding Options for Interventional Pain Management Physicians
FacetFuse is also rapidly being adopted by interventional pain management (IPM) physicians to provide a durable solution for patients with painful facet joints. Traditionally, IPM doctors offered these patients temporary relief through injections, radiofrequency ablation, and spinal cord stimulation, which often prolonged the degenerative disease progression until extensive reconstruction was necessary. Now, FacetFuse enables IPM doctors to deliver a lasting solution by addressing the source of pain earlier with a simple, LESS Exposure fusion. One IPM physician noted, “FacetFuse fits my expertise using fluoroscopy and allows me to offer patients with facet joint pain a more permanent solution rather than temporary relief, expanding our treatment options without requiring extensive spinal reconstruction surgery.”
The Evolution of FacetFuse: Innovation Without Costly Technology
Pedicle screws have been in use for over 50 years, with recent advancements focusing on costly robotic systems and imaging technologies to help spine surgeons avoid the risks associated with misplaced screws. FacetFuse, however, requires no expensive equipment and is designed for safe and easy insertion. This efficiency positions FacetFuse for rapid global adoption, expanding the reach of LESS Exposure Spine Surgery.
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“Since its FDA clearance in 2008, FacetFuse has continually evolved to maximize safety, ease of use, and rapid fusion outcomes,” said Vito Lore, CTO of KIC Ventures. “Each refinement focuses on delivering a stable, LESS Exposure solution that benefits both spine surgeons and IPM doctors. FacetFuse will continue to lead innovation in spine fusion.”
Positioning for Adoption: FacetFuse’s Strategic Edge
Aditya Humad, President and CFO of KIC Ventures, emphasized FacetFuse's market position: "FacetFuse represents a 'last mover advantage' in spinal fusion, positioning our NANISX portfolio for increased pull-through adoption among spine care professionals who are attracted to FacetFuse."
This study used cadaveric models to compare FacetFuse’s biomechanical stability with traditional pedicle screw-rod constructs, confirming that FacetFuse simplifies the fusion process while meeting stability requirements. This makes FacetFuse an ideal choice for patients in earlier stages of degenerative disease where the spine is still fairly stable, offering a reliable, LESS Exposure solution for spinal fusion.
FacetFuse and the Future of LESS Exposure Spine Surgery
FacetFuse, part of the NANISX portfolio owned by KIC Ventures, exemplifies the company’s commitment to advancing LESS Exposure Spine Surgery. Dr. Kingsley R. Chin, CEO of KIC Ventures, emphasized the broader impact: “FacetFuse embodies our LESS Exposure philosophy, transforming fusion surgery into a safer, more effective option. We’re providing physicians and patients with a revolutionary alternative to traditional techniques, with the potential for a broader range of care and earlier intervention.”
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For more information about FacetFuse and its role in transforming spine fusion surgery, visit www.kicventures.com.
Citation:
Chin KR, Seale JA, Bruce CA, Yu WD, Anagnost SC, Kushwaha VP, Sung RD, Gabriel J, Meyer CS, Crawford NR, Lore V. A comparative cadaveric biomechanical study of bilateral FacetFuse® transfacet pedicle screws versus bilateral or unilateral pedicle screw-rod construct. J Spine Surg. 2024 Sep 23;10(3):354-361. doi: 10.21037/jss-24-10.