FDA OKs Spinal Resources’ Solutions Based Spine Platform

Spinal technology company Spinal Resources has gained U.S. Food and Drug Administration (FDA) approval for its Solutions Based Spine Platform (SBSP). The platform was designed to assist in reduction of critical spinal conditions like proximal junctional kyphosis (PJK), proximal junctional failure (PJF), and adjacent segment disease (ASD).
 
The SBSP has a novel screw cap interface that toggles between a polyaxial and monoaxial head. The mechanism allows for free translation of the rod, facilitating screw head manipulation, compression, distraction, and coronal de-rotation.
 
“We are thrilled about the FDA-approval of our Solutions Based Spine Platform as it is a testament to our commitment to innovation and bringing spinal care forward,” Bernard M. Bedor, founder, president, and CEO of Spinal Resources told the press.
 
“In complex adult spinal surgery, the complications of non-union/rod fracture and proximal junctional failure (PJF) remain significant concerns, often driving revision surgery within the first year or two of an index operation. In some ways, these complications also counterbalance each other. Rod fracture is delayed or reduced by increasing the stiffness of the posterior rod construct. On the other hand, increased construct stiffness at the proximal junction can only increase the incidence of PJF,” said Dr. Robert Hart, Medical Director for Spinal Deformity at the Swedish Neuroscience Institute. “Creating a rod that is stronger at the caudal end of the construct but of reduced stiffness at the cranial end would be ideal. While there are several design approaches to addressing this concern, none are currently optimal. Specifically, short tapers in rod diameter are problematic. For one thing, they create a stress riser at the junction from larger to smaller diameter rods, increasing potential for rod failure. Further, they are difficult to contour as traditional rod bending tools accentuate curvature within the smaller diameter portion as opposed to the stiffer, larger diameter portion of the rod.”
 
Additional system features include:

• A range 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 blend of curved Morphotypes developed from post-operative data with seamless transitions between linear segments
• A Swedge pedicle Screw and Locking Cap system that allows for use of the entire rod, including the tapered segments
• Allows surgeons to tailor individual rod diameters to bone quality (individual diameters of 4.75, 5.0, 5.5, and 6.0 can be used alone in the same head and same locking cap allowing the reduction of micromotion and stress shielding which can lead to implant loosening.
• The Bezier Rod applies to Deformity and Degenerative surgeons allowing for a synergistic pathway between the two. The Bezier rod platform will have shorter-length rods allowing the technology to be used across several disciplines.

 
“This is a rod system that enhances the physiology of spinal fusion with respect to stress and strain rather than the stress shielding that occurs with larger diameter rods. The gradual taper accommodates the differing physiological needs to optimize stress and strain at all levels of the construct promoting solid fusion and providing a proximal soft landing to reduce the formation of a stress riser,” said Dr. Roland Kent, fellowship-trained Spine Surgeon and the co-founder of Axis Spine Center.
 
SRI is also building an AI platform with the ability to analyze forces and loads on adjacent segments based on in-situ functioning of the Bezier Rod and Bezier Rod Morphotype system. This aims to provide valuable insights into performance of the rods, cap, and screw interface, enabling better understanding of the forces unloaded at the adjacent segment and the potential occurrence of failure at the adjacent segment.
 
“The SRI system represents a significant advancement in the technology available in my surgical armamentarium. It allows for an array of interoperative choices based upon patient bone density, segment, and mobility of the spine. This provides intraoperative flexibility, using multiple rod diameters which allows surgeons to tailor patient-focused rods and solutions. This is seamlessly achieved by customizing the linear segments and transitions and controlling the flex of the rod. The result is a more even distribution of forces across the construct, unloading the proximal and distal segments,” said Dr. Hamid Hassanzadeh, Chief of Orthopaedic Surgery at Johns Hopkins.