155 - Early Outcomes of the Discure System for the Treatment of Lumbar Degenerative Disc Disease: A Prospective Multicenter Feasibility Study

Purpose: Prospective, single center, open-label, multicenter feasibility trial.

Materials and Methods: Ten patients were enrolled at Beam Radiology Clinic in Calgary, Canada. All underwent implantation of the Discure System under local anesthesia, with treatment initiation prior to discharge. Pain intensity, and disability levels were measured at baseline and during follow-up using the Visual Analog Scale (VAS) for back pain, and the Oswestry Disability Index (ODI). The minimum clinically important difference (MCID) for VAS and for ODI was defined as a ≥30% reduction from baseline. All serious adverse events, whether related or unrelated to the device or procedure, were recorded.

Results: Low back pain and disability scores, measured using VAS and ODI respectively, improved across all follow-up periods. Mean single-point VAS decreased from 6.1 cm to 2.6 cm at 1 month (n=10; 56.6% reduction, 70% achieving MCID; p< 0.001), from 6.2 cm to 2.4 cm at 3 months (n=5; 61.3% reduction, 60% achieving MCID), and from 6.0 cm to 2.5 cm at 6 months (n=2; 58.3% reduction, 50% achieving MCID). Seven-day diary VAS scores demonstrated similar improvements. Functional outcomes also improved, with mean Oswestry Disability Index (ODI) scores decreasing from 46.5 to 25.9 at 1 month (n=10, 44.4% improvement, 70% achieving MCID; p< 0.001), from 42.6 to 20.5 at 3 months (n=5, 52% improvement, 80% achieving MCID), and from 34.5 to 28.1 at 6 months (n=2, 18.6% improvement). No device- or procedure-related serious adverse events were observed.

Conclusion: Over a one- to six-month period, implantation of the Discure System and induction of negative charge to the nucleus pulposus resulted in clinically meaningful and durable improvements in pain and function, with a favorable safety profile, in patients with low back pain associated with early to moderate degenerative disc disease.