enspire Interventional, Novel approach in Percutaneous Discectomy in Percutaneous Discectomy Samyadev Datta, MD, FRCA Center for Pain Management

enspire Interventional, Novel approach in Percutaneous Discectomy in Percutaneous Discectomy Samyadev Datta, MD, FRCA Center for Pain Management

Anatomy Intervertebral Disc: Fibrocartilaginous joint Makes up ¼ the length of the spinal column Present at levels C2-C3 to L5-S1 Allows compressive, tensile, and rotational motion

Anatomy Intervertebral Disc Annulus Fibrosus Made up of 2 parts - Outer annulus fibrosis - Inner nucleus pulposus Nucleus Pulposus

Pathology Bulging or protruding discs: A bulging or protruding disc is a contained disc disorder. This means the nucleus pulposus remains contained within the annulus fibrosus of the disc. Kraemer, Juergen. Intervertebral Disk Diseases: Causes, Diagnosis, Treatment, and Prophylaxis. Stuttgart: Georg Thieme Verlag, 2009.

Pathology Herniated discs: A herniated disc presents when the nucleus pulposus prolapses and stresses the annulus fibrosis, but does not necessarily rupture the annulus. Kraemer, Juergen. Intervertebral Disk Diseases: Causes, Diagnosis, Treatment, and Prophylaxis. Stuttgart: Georg Thieme Verlag, 2009.

Pathology Herniated discs: A disc extrusion is a more severe herniation in which the annulus fibrosis is perforated and material of the nucleus moves into the epidural space, but still remains contiguous with the disc proper. Kraemer, Juergen. Intervertebral Disk Diseases: Causes, Diagnosis, Treatment, and Prophylaxis. Stuttgart: Georg Thieme Verlag, 2009.

Treatment Options Percutaneous Discectomy (the enspire Interventional Discectomy) Endoscopic Discectomy Surgical Discectomy w/out & w/fusion Increasing Invasiveness Conservative Management Bed Rest, Oral Pain Medications Physical Therapy, Acupuncture, Epidural Injections

Principles in Percutaneous Discectomy Assessment: History and physical Patient selection: Has tried all other conservative and minimally invasive procedures. No red flags. Disc has been identified by discogram Good technique: Infection must be avoided. Trauma to tissue, nerves etc. Forewarn patients about what to expect Adequate follow up: Needs to have physical therapy after discectomy to maximize results

Red Flags in Disc procedures Suspected unstable fractures of the spine History of cancer with suspicion of metastatic spread Infection with suspicion of an epidural abscess or discitis Cauda equina syndrome Short history of pain processess Axial pain Facet diseases Central Pain Syndromes

Treatment Options Evolution of Percutaneous Discectomy Chymopapain Injections ( 64) Smith, enzymatic dissolution of nucleus. Percutaneous Nucleotomy ( 75) Hajikata, nucleotomy w/ manual instruments/pituitary via 3-5mm cannula. Percutaneous Lumbar Discectomy ( 85) Onik, nucleotome/ APLD, 2.5mm, automated mechanical, slice/aspirate 20-40min Laser Diskectomy ( 87) Choy/Ascher, evaporate nucleus, 18g. Nucleoplasty ( 00) Arthrocare, RF ablation device to vaporize nucleus. Percutaneous Discectomy ( 02) - Pain Concepts, 17g mechanical auger run time 10min (now Stryker DeKompressor).

Published Literature: Stryker Amoretti et al. Clin Imaging 2006; 30:242-244. Cohort of 50 patients (median age 52 yrs w/ range 22-81yrs) At 6 months, 36 (72%) had very good results, 11 (22%) had bad results. Location correlated with degree of success. 70% diminution of symptoms in 50% of posteromedian cases, 80% diminution in lateral herniations.

Published Literature: Arthrocare

Published Literature: APLD Company Confidential DO NOT DISTRIBUTE

Not all surgical discectomies have the same outcome Adjusted Kaplan-Meier plot of sciatica-free survival according to herniation type. Carragee, et. al. Clinical outcomes after lumbar discectomy for sciatica: The effects of fragment type and anular competence. JBJS. 85:102-108,2003.

The SpineView Solution

The enspire Device Indications The SpineView enspire Interventional Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the lumbar spine, particularly percutaneous discectomies in contained herniations.

The enspire Device Contraindications Contraindications for the enspire device include but are not limited to patients with: Active systemic or local infection Discitis Irreversible coagulopathy or bleeding disorder Allergy to any device materials, including nickel Pregnancy

The enspire Device Slider Deploys Wire Cap Travel LimiterLocking Ring The Device On/Off Switch Tissue Collection Chamber Auger Aspirates Tissue Deployable Wire Cuts and Grinds tissue

The enspire Device Locking Ring As packaged in fully distal position The Device The Travel Limiter 1 cc ½ cc Proximal Distal Locked 5mm 10mm Locking Ring Retracted Cannula Hub

The enspire Device The enspire Device s Deploying Wire has a 7mm sweep diameter The device tip extends 10 mm from the tip of the Cannula Retracting the Travel Limiter Locking Ring allows the device tip to advance up to 20 mm beyond the tip of the Cannula 3.5 mm reach 7 mm MAX sweep Dia. 10mm 20 mm

Surgical Technique Access, cont d Lateral Fluoroscopic Positioning Advanced through the posterior annulus 1/3 of the way into disc space Parallel and equidistant from the endplates -

Surgical Technique

1. 2. Pilot Hole 20mm Insert Cannula/Stylet in disc up to 20mm (max device travel) beyond annulus to create a pilot hole. Pull Cannula back to Initial position and remove Stylet 4. *Discogram approach. Place skin stop 10mm 3. 10mm Squeeze and Retract the Locking Ring to the desired position to allow the device tip a 5 mm or 10 mm travel depth. 10mm distal travel (max) and 10mm tip = a 20mm distance beyond Cannula Summary Slide 10mm While the device is on, hold the Cannula Hub and slowly advance and retract the device repeatedly to facilitate tissue removal. Run the device until sufficient material has been removed.

Surgical Technique 1. 2. 3. 4. 5. Position the patient prone on a Wilson table or with pillow support under the abdomen in order to reduce the lumbar lordotic curve. Under fluoroscopic guidance, using the Oblique view, insert the Stylet and Cannula through Kambin s triangle and into the disc space (discogram approach). Use A/P and Lateral fluoroscopic views to confirm the needle tip 1/3 of the way into the disc space, and equidistant and parallel to the endplates. Create a Pilot Hole. Once inside disc space, advance the Cannula 2cm. Then pull the Cannula back 2cm and the pilot hole is formed. Position the skin stop distally until contact is made with the patient s skin.

Surgical Technique 11. Turn the device on and then deploy the wire. 12. Use one hand to hold the Cannula in place. 13. 14. 15. Use the other hand to gently move the device back and forth within the disc space with distance being controlled by the Travel Limiter. Allow device to run for ~2 minutes and see the disc material collect in the Collection Chamber. If repositioning is necessary, always turn off the device, retract the wire, and remove the device prior to inserting the needle back into the Cannula. Then carefully reposition the needle and Cannula under fluoroscopic guidance.

Troubleshooting ALWAYS Utilize at least 2 different fluoro views to confirm and document the correct central placement of the device within the disc Confirm with fluoro the position of the device when retracted and fully advanced ALWAYS Keep the device straight while advanced Replace the enspire device with Stylet and reposition if contact is made between the activated device and the endplates or annulus Reposition by removing device, replacing Stylet, and then repositioning as appropriate Temporarily deactivate the device and assess the source if resistance is encountered while advancing or you hear the motor slowing Stabilize both the Cannula and device handle when using the enspire device

Features and Benefits Features Benefits Deployable Wire Deploys to 7mm sweep diameter Tissue selective Wire cuts/removes nucleus but deflects off annulus, thus removing only the intended intra-disc material safely and with precision. Travel Limiter Allows for added safety and control of device tip while in the disc space Flexible shaft Makes the device easier to use and minimizes torque placed on spinal anatomy

Features and Benefits Features Benefits Stationary Cannula allows for minimal passes Stationary Cannula is safer in that it allows for greater control while minimizing device passes Procedure takes 1-2 min. total Simpler & faster discectomy See tissue every time in Collection Chamber Safely control the amount of tissue removed from disc space. Ensures no vascular tissue is removed

Conclusion Finally enspire Interventional is a novel, safe, and highly effective alternative for percutaneous disc decompression in contained disc causing radicular pain. Thank you. Ciao