Spinal Resources, a spinal medical device company, has secured approval from the US Food and Drug Administration (FDA) for its Solutions Based Spine Platform (SBSP).
The new Bezier Rod platform is designed to support the treatment of critical spinal conditions such as adjacent segment disease (ASD), proximal junctional kyphosis (PJK), and proximal junctional failure (PJF) apart from improving patient care.
The Solutions Based Spine Platform has a screw cap interface that switches between a polyaxial and monoaxial head.
According to the Florida-based company, the mechanism enables free translation of the rod, manipulation of the screw head, coronal de-rotation, compression, and distraction.
Spinal Resources founder, president, and CEO Bernard Bedor said: “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.”
The Solutions Based Spine Platform is said to provide a range of Bezier Taper transition rods and curved morphotypes developed using post-operative data with transitions between linear segments.
Additionally, it has the Swedge pedicle Screw and Locking Cap system that enables the entire rod to be used, including the tapered segments to offer flexibility during surgery.
The spinal medical device company said that Bezier Rod is useful for deformity and degenerative surgeons to facilitate a synergistic pathway between them. The presence of shorter-length rods in the platform will allow the use of technology across various disciplines, said Spinal Resources.
Furthermore, the Bezier Rod platform can also help surgeons to customise individual rod diameters as per the bone quality.
Spinal Resources is also working on the development of an artificial intelligence (AI) platform with capabilities to lower the forces and loads on nearby segments using the in-situ functioning of the Bezier Rod Morphotype system and Bezier Rod.
This will offer insights into the performance of the rods, screw interface, and cap to better understand the forces unloaded at the adjacent segment as well as a possible failure.
Using an advanced AI technology and the firm’s rod system, the platform is intended to provide a robust and new approach to spinal care, according to the medical technology firm.
