KILKENNY, Ireland, Nov. 15, 2022 /PRNewswire/ -- Spinal Stabilization Technologies (SST) has announced the start of the LOPAIN2 clinical trial of the PerQdisc™ Nucleus Replacement Device (NRD).
SST's PerQdisc Nucleus Replacement Device will be studied in patients with degenerative disc disease (DDD) of the lumbar spine, which causes severe back pain, in patients without stenosis or instability. The PerQdisc is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using an anterior or lateral transpsoas approach. Currently, there is no good surgical option for these patients. SST's PerQdisc NRD aims to treat discogenic low back pain while maintaining disc height and preserving range of motion.
This trial is enrolling 72 patients and taking place in seven research centers in South America. Data from the LOPAIN2 trials will be used to file for the CE Mark under the Medical Device Regulation (MDR) in Europe. The LOPAIN2 trial is registered on clinicaltrials.gov (NCT05508360).
"We're impressed with the quality of clinical trial research in the South American region," said Mark Novotny, CEO of SST. "These are advanced research centers with fully staffed research teams. The patient care and follow-up are excellent. In an earlier trial, no patient was lost to follow-up. The surgeons and their research staff we are working with are all highly trained in clinical research and motivated to make our trials in South America a success."
Dr. Javier Duarte, principal, investigator at Hospital Americano in Asuncion Paraguay, the largest enroller in the overall SST clinical trial program, stated, "The results I'm getting with the PerQdisc are excellent. I have been able to refine the technique to a point where I'm comfortable routinely offering the option to my DDD patients."
"I believe nucleus replacement is finally here to stay. I enrolled and treated the first patient in LOPAIN2. The procedure is easy to learn, and the result is a custom implant that is fitted perfectly to the patient's anatomy," added Dr. Rodolfo Paez, principal investigator at Hospital de San José in Bogota, Colombia.
SST will attend numerous meetings in 2023 to present the clinical data from its programs and present the technique to surgeons worldwide.
Spinal Stabilization Technologies, Ltd (SST), an Irish company headquartered in Kilkenny, Ireland, develops novel technologies for treating patients with lumbar discogenic back pain. SST's products and techniques are based on the philosophy that less invasive surgery may be associated with better clinical outcomes and could improve the lives of many patients with limited options for treating their back pain. The company has extensive worldwide intellectual property and is focused on evidence-based medicine.
For more information, physicians may visit https://www.sstspine.com/
SOURCE Spinal Stabilization Technologies