FDA-approved Bezier Rod platform offers an unparalleled answer to deal with vital spinal situations and enhance affected person outcomes.
FORT LAUDERDALE, FL., April 5, 2023 /OrthoSpineNews/ –
Spinal Sources Inc. (SRI), a number one innovator in spinal know-how, has introduced the FDA-approval of its state-of-the-art, Options Based mostly Backbone Platform (SBSP). The distinctive platform is designed to supply surgeons with an unparalleled answer to deal with and help within the discount of vital spinal situations like Proximal Junctional Kyphosis (PJK), Proximal Junctional Failure (PJF), and Adjoining Phase Illness (ASD).
The Options Based mostly Backbone Platform encompasses a novel screw cap interface that toggles between a polyaxial and monoaxial head. This distinctive mechanism permits without cost translation of the rod, facilitating screw head manipulation, compression, distraction, and coronal de-rotation. “We’re thrilled concerning the FDA-approval of our Options Based mostly Backbone Platform as it’s a testomony to our dedication to innovation and bringing spinal care ahead,” mentioned Bernard M. Bedor, Founder, President, and CEO of Spinal Sources Inc.
“In complicated grownup spinal surgical procedure, the problems of non-union/rod fracture and proximal junctional failure (PJF) stay vital considerations, usually driving revision surgical procedure inside the first 12 months or two of an index operation. In some methods, these problems additionally counterbalance one another. Rod fracture is delayed or diminished by rising the stiffness of the posterior rod assemble. However, elevated assemble stiffness on the proximal junction can solely improve the incidence of PJF’” mentioned Dr. Robert Hart, Medical Director for Spinal Deformity on the Swedish Neuroscience Institute. “Making a rod that’s stronger on the caudal finish of the assemble however of diminished stiffness on the cranial finish could be ultimate. Whereas there are a number of design approaches to addressing this concern, none are at the moment optimum. Particularly, quick tapers in rod diameter are problematic. For one factor, they create a stress riser on the junction from bigger to smaller diameter rods, rising potential for rod failure. Additional, they’re troublesome to contour as conventional rod bending instruments intensify curvature inside the smaller diameter portion versus the stiffer, bigger diameter portion of the rod.”
Further options of the system embody:
- A spread of Bezier Taper transition rods (4.75, 5.0, 5.5, 6.0), ( 4.75,5.0, 5.5) ( 5.0, 5.5, 6.0)
- A singular mix of curved Morphotypes which have been developed from post-operative knowledge with seamless transitions between linear segments
- A Swedge pedicle Screw and Locking Cap system that permits for using the whole rod, together with the tapered segments, offering flexibility intraoperatively.
- Permits surgeons to tailor particular person rod diameters to bone high quality (particular person diameters of 4.75, 5.0, 5.5, and 6.0 can be utilized alone in the identical head and similar locking cap permitting the discount of micromotion and stress shielding which might result in implant loosening
- The Bezier Rod applies to Deformity and Degenerative surgeons permitting for a synergistic pathway between the 2. The Bezier rod platform may have shorter-length rods permitting the know-how for use throughout a number of disciplines.
“It is a rod system that enhances the physiology of spinal fusion with respect to emphasize and pressure fairly than the stress shielding that happens with bigger diameter rods. The gradual taper accommodates the differing physiological must optimize stress and pressure in any respect ranges of the assemble selling stable fusion and offering a proximal comfortable touchdown to cut back the formation of a stress riser,” mentioned Dr. Roland Kent, fellowship-trained Backbone Surgeon and the co-founder of Axis Backbone Middle.
SRI can be creating an AI platform that can have the flexibility to the forces and masses on adjoining segments based mostly on the in-situ functioning of the Bezier Rod and Bezier Rod Morphotype system. This revolutionary function will present beneficial insights into the efficiency of the rods, cap, and screw interface, enabling a greater understanding of the forces unloaded on the adjoining phase and the potential incidence of failure on the adjoining phase. The platform provides a sturdy, biomechanically sound, and revolutionary method to spinal care, leveraging our distinctive rod system and cutting-edge AI know-how.
“The SRI system represents a big development within the know-how obtainable in my surgical armamentarium. It permits for an array of interoperative decisions based mostly upon affected person bone density, phase, and mobility of the spine. This offers intraoperative flexibility, utilizing a number of rod diameters which permits surgeons to tailor patient-focused rods and options. That is seamlessly achieved by customizing the linear segments and transitions and controlling the flex of the rod. The result’s a extra even distribution of forces throughout the assemble, unloading the proximal and distal segments” mentioned Dr. Hamid Hassanzadeh, Chief of Orthopaedic Surgical procedure at Johns Hopkins.
For extra details about Spinal Sources Inc. and its Options Based mostly Backbone Platform, please go to http://spinalresourcesinc.com/ or contact the media relations workforce.
About Spinal Sources, Inc.
Spinal Sources, Inc. (SRI) is a Florida-based spinal medical gadget firm that gives revolutionary mechanical and biomechanical merchandise to assist cost-effective affected person care, alleviate ache, shorten restoration time, restore well being, and prolong high quality of life. SRI has engineered a novel line of patented open, discount, and minimally-invasive spinal methods for the surgical restore and reconstruction of debilitating spinal situations. With a give attention to innovation, SRI is dedicated to creating groundbreaking applied sciences that tackle vital spinal situations.
Spinal Sources Inc