KILKENNY, Eire, Nov. 15, 2022 /PRNewswire/ — Spinal Stabilization Applied sciences (SST) has introduced the beginning of the LOPAIN2 scientific trial of the PerQdisc™ Nucleus Substitute System (NRD).
SST’s PerQdisc Nucleus Substitute System shall be studied in sufferers with degenerative disc illness (DDD) of the lumbar spine, which causes extreme again ache, in sufferers with out stenosis or instability. The PerQdisc is used for surgical alternative of a single nucleus pulposus between spinal lumbar discs L1-S1 utilizing an anterior or lateral transpsoas strategy. At present, there is no such thing as a good surgical choice for these sufferers. SST’s PerQdisc NRD goals to deal with discogenic low again ache whereas sustaining disc top and preserving vary of movement.
This trial is enrolling 72 sufferers and going down in seven analysis facilities in South America. Information from the LOPAIN2 trials shall be used to file for the CE Mark below the Medical System Regulation (MDR) in Europe. The LOPAIN2 trial is registered on clinicaltrials.gov (NCT05508360).
“We’re impressed with the standard of scientific trial analysis within the South American area,” stated Mark Novotny, CEO of SST. “These are superior analysis facilities with totally staffed analysis groups. The affected person care and follow-up are glorious. In an earlier trial, no affected person was misplaced to follow-up. The surgeons and their analysis employees we’re working with are all extremely educated in scientific analysis and motivated to make our trials in South America a hit.”
Dr. Javier Duarte, principal, investigator at Hospital Americano in Asuncion Paraguay, the most important enroller within the general SST scientific trial program, said, “The outcomes I’m getting with the PerQdisc are glorious. I’ve been capable of refine the method to a degree the place I’m comfy routinely providing the choice to my DDD sufferers.”
“I imagine nucleus alternative is lastly right here to remain. I enrolled and handled the primary affected person in LOPAIN2. The process is simple to be taught, and the result’s a customized implant that’s fitted completely to the affected person’s anatomy,” added Dr. Rodolfo Paez, principal investigator at Hospital de San José in Bogota, Colombia.
SST will attend quite a few conferences in 2023 to current the scientific information from its applications and current the method to surgeons worldwide.
About Spinal Stabilization Applied sciences, Ltd
Spinal Stabilization Applied sciences, Ltd (SST), an Irish firm headquartered in Kilkenny, Eire, develops novel applied sciences for treating sufferers with lumbar discogenic again ache. SST’s merchandise and strategies are based mostly on the philosophy that much less invasive surgical procedure could also be related to higher scientific outcomes and will enhance the lives of many sufferers with restricted choices for treating their again ache. The corporate has intensive worldwide mental property and is concentrated on evidence-based drugs.
For extra data, physicians could go to https://www.sstspine.com/
SOURCE Spinal Stabilization Applied sciences