Spinal Stabilization Technologies
Medical device company developing a minimally invasive nucleus pulposus replacement technology and associated access and delivery systems for treatment of degenerative disc disease. Activities described on the site include device design (in-situ curing silicone implant), surgical procedure development for lateral/transpsoas and retroperitoneal approaches, clinical trials (feasibility and safety/efficacy studies), device verification/validation and regulatory/quality management.
Industries
Nr. of Employees
small (1-50)
Spinal Stabilization Technologies
Patents
Products
Nucleus replacement implant system (in‑situ curing silicone polymer)
A minimally invasive, patient‑specific nucleus replacement comprised of a malleable dual‑chamber membrane. The inner chamber is filled with radiopaque contrast for visualization; the outer chamber is filled with an in‑situ curing silicone polymer (radiopaque filler) that cures at body temperature. Delivered via a disc access system and an implant delivery device.
PerQdisc™ Nucleus Replacement System
The PerQdisc Nucleus Replacement System is intended to replace the nucleus pulposus of the intervertebral disc in the L1-S1 spinal region in patients with single-level discogenic pain. It uses a patient-specific, form-fitting, custom implant to recreate physiological motion and redistribute the disc's weight-bearing forces naturally.
SST PerQdisc Nucleus Replacement System (REF 9011)
The SST PerQdisc Nucleus Replacement System is intended to replace the nucleus pulposus of the intervertebral disc in the L1-S1 spinal region in patients with single level discogenic pain, aged 22-70, with moderate to severe low back pain unresponsive to conservative treatments.
SST PerQdisc TM Nucleus Replacement System (REF 9012)
The SST PerQdisc TM Nucleus Replacement System is intended to replace the nucleus pulposus and support the annulus fibrosis of the intervertebral disc in the L1-S1 spinal region in patients with symptomatic radiculopathy from a focal lumbar disc herniation undergoing partial discectomy and/or sequestrectomy.
lumbar implant for nucleus pulposus replacement
A lumbar implant designed to replace the damaged nucleus pulposus to alleviate some types of lower back pain. It is implanted using a new surgical procedure and tool set that accesses the internal anatomy of a lumbar disc, removes the damaged nucleus pulposus, and replaces it with a long-term implant designed to bear the load and forces of the lumbar disc.
Nucleus replacement implant system (in‑situ curing silicone polymer)
A minimally invasive, patient‑specific nucleus replacement comprised of a malleable dual‑chamber membrane. The inner chamber is filled with radiopaque contrast for visualization; the outer chamber is filled with an in‑situ curing silicone polymer (radiopaque filler) that cures at body temperature. Delivered via a disc access system and an implant delivery device.
PerQdisc™ Nucleus Replacement System
The PerQdisc Nucleus Replacement System is intended to replace the nucleus pulposus of the intervertebral disc in the L1-S1 spinal region in patients with single-level discogenic pain. It uses a patient-specific, form-fitting, custom implant to recreate physiological motion and redistribute the disc's weight-bearing forces naturally.
SST PerQdisc Nucleus Replacement System (REF 9011)
The SST PerQdisc Nucleus Replacement System is intended to replace the nucleus pulposus of the intervertebral disc in the L1-S1 spinal region in patients with single level discogenic pain, aged 22-70, with moderate to severe low back pain unresponsive to conservative treatments.
SST PerQdisc TM Nucleus Replacement System (REF 9012)
The SST PerQdisc TM Nucleus Replacement System is intended to replace the nucleus pulposus and support the annulus fibrosis of the intervertebral disc in the L1-S1 spinal region in patients with symptomatic radiculopathy from a focal lumbar disc herniation undergoing partial discectomy and/or sequestrectomy.
lumbar implant for nucleus pulposus replacement
A lumbar implant designed to replace the damaged nucleus pulposus to alleviate some types of lower back pain. It is implanted using a new surgical procedure and tool set that accesses the internal anatomy of a lumbar disc, removes the damaged nucleus pulposus, and replaces it with a long-term implant designed to bear the load and forces of the lumbar disc.
Services
Feasibility, safety and efficacy clinical studies including site selection, patient screening, standardized outcome collection and imaging follow‑up.
Controlled access training videos and a surgical technique whitepaper to support clinician education and device preparation.
Feasibility, safety and efficacy clinical studies including site selection, patient screening, standardized outcome collection and imaging follow‑up.
Controlled access training videos and a surgical technique whitepaper to support clinician education and device preparation.
Expertise Areas
- Minimally invasive spinal implants
- Nucleus pulposus replacement
- Clinical trial management for implantable devices
- Medical device regulatory compliance and quality systems
Key Technologies
- In‑situ curing silicone polymer implants
- Dual‑chamber implant with radiopaque inner chamber
- Implant delivery device and disc access cannula
- Lateral transpsoas and retroperitoneal surgical approaches
News & Updates
Announcement of enrollment of first U.S. patient in an IDE trial for the nucleus replacement device.
Press item reporting achievement of CE Mark and FDA Breakthrough Device designation for the nucleus replacement system.
Announcement of start of the LOPAIN2 clinical trial to measure efficacy of the nucleus replacement device.
Announcement of enrollment of first U.S. patient in an IDE trial for the nucleus replacement device.
Press item reporting achievement of CE Mark and FDA Breakthrough Device designation for the nucleus replacement system.
Announcement of start of the LOPAIN2 clinical trial to measure efficacy of the nucleus replacement device.