The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for Dymicron to initiate a pivotal trial of its Triadyme-C cervical artificial disc, a significant step towards offering a solution for individuals with degenerative disc disease.
The prospective, multi-centre, historically controlled trial is set to compare the safety and effectiveness of the Triadyme-C disc against anterior cervical discectomy and fusion (ACDF) surgery in treating symptomatic cervical disc disease (SCDD).
It will take place across various spine centres in the US, with the first implantations anticipated in the fourth quarter of this year.
The trial’s primary endpoint is composite clinical success, which is defined by improvement in the Neck Disability Index (NDI) Score and neurological status, and the absence of secondary surgical interventions.
The data collected from this trial will be instrumental in supporting a future premarket approval (PMA) submission to the agency.
Triadyme-C comprises bearing surfaces that are made from the company鈥檚 medical-grade polycrystalline diamond material called Adymite.
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By GlobalDataThis material is designed for high-stress load-bearing environments and aims to significantly decrease wear debris generation, a common issue with traditional implant materials that is associated with prolonged complications and revision surgeries.
It provides Triadyme-C with hardness and low friction, tailored for the demands of spinal motion preservation.
With its patented Tri-Lobe design, the system is engineered to replicate the natural kinematics and a healthy disc motion.
Dymicron CEO and board chairman Alan Layton said: “This FDA approval is a value-defining achievement for Dymicron.
“It reflects both the strength of our technology and the disciplined execution of our regulatory roadmap. We are now poised to generate high-quality clinical data that will support a future PMA [premarket approval] submission and lay the groundwork for commercialisation in the US market.”
