Michael Barbella, Managing Editor11.16.22
Spinal Stabilization Technologies (SST) has begun its LOPAIN2 clinical trial, measuring the efficacy of the PerQdisc Nucleus Replacement Device (NRD).
"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," stated Dr. Javier Duarte, principal investigator at Hospital Americano in Asuncion Paraguay, the largest enroller in SST's clinical trial program.
SST's PerQdisc Nucleus Replacement Device will be analyzed in patients suffering from lumbar spine degenerative disc disease (DDD), which can cause severe back pain. The PerQdisc is used to replace 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.
"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," said Dr. Rodolfo Paez, principal investigator at Hospital de San José in Bogota, Colombia.
This trial is enrolling 72 patients and taking place in seven South American research centers. Data from the LOPAIN2 trials will be used to file for a CE Mark under the Medical Device Regulation (MDR) in Europe.
"We're impressed with the quality of clinical trial research in the South American region," SST CEO Mark Novotny said. "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."
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 technologies to treat 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 patients' lives. The company has worldwide intellectual property and is focused on evidence-based medicine.
"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," stated Dr. Javier Duarte, principal investigator at Hospital Americano in Asuncion Paraguay, the largest enroller in SST's clinical trial program.
SST's PerQdisc Nucleus Replacement Device will be analyzed in patients suffering from lumbar spine degenerative disc disease (DDD), which can cause severe back pain. The PerQdisc is used to replace 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.
"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," said Dr. Rodolfo Paez, principal investigator at Hospital de San José in Bogota, Colombia.
This trial is enrolling 72 patients and taking place in seven South American research centers. Data from the LOPAIN2 trials will be used to file for a CE Mark under the Medical Device Regulation (MDR) in Europe.
"We're impressed with the quality of clinical trial research in the South American region," SST CEO Mark Novotny said. "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."
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 technologies to treat 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 patients' lives. The company has worldwide intellectual property and is focused on evidence-based medicine.