526 - Interim Study Results of a Flexible Microblade Shaver System for Lumba...

#526 Interim Study Results of a Flexible Microblade Shaver System for Lumbar Decompression

Oral Posters: MIS

Presented by: L. Dickinson

Author(s):

L. Dickinson (1)
C. Summa (2)
R. Mimran (1)
C. Lauryssen (3)

(1) Pacific Brain & Spine Medical Group, Inc., Castro Valley, CA, USA
(2) Spine Clinic of Monterrey Bay, Soquel, CA, USA
(3) Tower Orthopaedics and Neurological Spine Institute, Beverly Hills, CA, USA

Abstract

Background: Inadequate diagnosis and treatment of lumbar spinal stenosis, particularly lateral and foraminal stenosis, is a leading cause of failed decompression. Accessing and decompressing the neural elements lateral of the central canal can be challenging using traditional ridged tools often leading to substantial removal of the facet joint and fusion. A flexible microblade shaving system (iO-Flex® System) was developed to target central canal, lateral recess, and foramen stenosis with minimal disruption to healthy anatomy critical for maintaining spinal stability.

Methods: Early outcomes for the first 51 patients enrolled in a two-year follow-up prospective, single-arm, multi-center trial demonstrating the effectiveness of the iO-Flex® System in reducing pain and symptom severity in patients with one- or two-level lumbar spinal stenosis are presented.

Results: Interim analysis was performed on 51 patients at baseline, 39 at 6 weeks, 35 at 3 months, 27 at 6 months, and 14 at 12 months. Oswestry Disability Index (ODI) scores decreased on average by 49% (21.7 ± 16.1 points, mean ± standard deviation), 57% (17.5 ± 15.1), 60% (17.8 ± 16.5), and 56% (21.9 ± 16.5) at each respective time point compared to baseline. Mean VAS leg and back pain decreased at 6 weeks (leg 5.4 baseline to 1.9, back 4.8 to 1.9) and was sustained through 12 months (leg 1.4, back 1.7). Average surgical time and estimated blood loss (EBL) during the procedure was 86 minutes (SD 37) and 131 mL (SD 109). Length of hospital stay (LOS) was 1.3 (SD 1.1) days on average. Intra-operative and discharge results are favorable compared to a subgroup analysis of SPORT LSS decompression-treated patients with radicular pain symptoms (OR Time 105 ± 46 min, EBL 175 ± 179, LOS 2.4 ± 1.8).

Conclusions: Early results show a positive trend of rapid and sustained improvement. Improved results compared to data reported on the surgically treated patients in SPORT LSS are also very encouraging. The improved patient-reported outcomes and peri-operative metrics demonstrate the potential of the iO-Flex® System to address challenges of traditional decompression while preserving healthy tissue and facet joint integrity.