February 22, 2020 10:45am
ADVANCES IN PAIN MANAGEMENT
www.painmanagement.org
NSU-COM Class of 2005
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Introduction and Objectives
• Intracept® Procedure
• Intracept Procedure is designed to target and ablate the basivertebral nerve (“BVN”) within a vertebralbody
• Intracept Access Instruments create a path to treatment location
• Intracept Flexible Bi-polar RF Probe for the ablation of the BVN
• Objective
• Educate on the Intracept®
Intraosseous Nerve Ablation System for the relief of chronic low back pain
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The Chronic LBP Patient – Healthcare Burden
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LBP is the most common cause of job-related disability1
• Impacts 29% of the population2
• $150-200 billion in annual healthcare expenditures3
• 33 million people disabled4
• 102 million lost workdays annually5
Source:1 National Institute of Neurological Disorders and Stroke (2014) Back Pain Fact Sheet2,3,4 The Burden of Musculoskeletal Diseases in the United States - Copyright 20115 Back pain prevalence in US industry and estimates of lost workdays, Am J Public Health. 1999 July; 89(7): 1029–1035.
Patient Care Continuum
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While some patients find relief with conservative therapy, the majority do not get adequate relief.
Meds
Physical Therapy
ChiropracticCare
InjectionsTENS
Structured Rehab
Opioids
Conservative
Treatment
Options for
CLBP72%
NO RELIEF
2%SURGERY
26%SYMPTOM
RELIEF
Chronic Lower Back Pain in the USA
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30MPeople Living with
Chronic Low Back Pain in US
900KNew Incidences of Patients with
Chronic Low Back Pain in US
Navigant Research Report
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• Loss of hydration, becoming more friable
• Blood vessel ingrowth → Nerve
ingrowth into posterior annulus
• Internal disc disruption occurs,
leading to full thickness fissures
• Chemical and mechanical
sensitization of nociceptors lead to
LBP
DDD ~ #1 source of pain in patients with ‘non-specific’LBP
• Loss of hydration, becoming more friable
• Blood vessel ingrowth → Nerve ingrowth into
posterior annulus
• Internal disc disruption occurs, leading to full
thickness fissures
• Chemical and mechanical sensitization of
nociceptors lead to LBP
The Traditional Discogenic Pain Model
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• Asymptomatic lumbar DDD in 57% of adults
• Asymptomatic lumbar DDD in 93% of adults > 60
years of age
Boden et al.
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Link Between DDD and LBP is Weak
Modic Type 1 (1 tissue hyper-intense):
• Hypointense T1W
• Hyperintense T2W MR images
Modic Type 2 (2 tissues hyper-intense):
• Hyperintense T1W and T2W MR images
MRI T2 (fat and water)MRI T1 (fat)
MRI Findings with MC1 and MC2
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1 Carragee el al.2 Jensen et al. (2014)3 Jensen el al. (2011,2014)4 Lurie et al. (2013)5 Mok et al.
The Case for Vertebrogenic Pain
LBP patients with MC vs. LBP patients without MC
• MC changes were associated with persistent LBP1
• These patients seek care more often2, however,
• MC1 with chronic LBP associated with poor outcomes to conservative treatment3
• MC1 patients had worse outcomes after discectomy, underscoring the role of the
vertebra as a possible pain generator4
• MC were associated with historical LBP, and with severity and duration of symptoms
(p<.05)5
• Failed Facet Radiofrequency Ablation
• Failed Epidural Steroid Injections
• Failed SI joint Injections• Failed SI joint peripheral nerve
ablation• Failed laminotomy
• Success with Basivertebralnerve ablation (IntraceptProcedure)
Modic Changes – Anatomical Changes and Imaging
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T1
T2
Modic 1 Modic 2 Modic 3Modic
Change1 2 3
MRI
T1Low High Low
MRI
T2High
High-
intermediateLow
Implication
Marrow
inflammation
and edema
Fatty
replacement
of marrow
Trabecular
micro-fracture
and sclerosis
Hypointense HyperintenseIsointense
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Vertebral bodies and endplates are innervated
principally by the Basivertebral Nerve (BVN)1
• BVN enters the vertebral body via the
Basivertebral Foramen (BVF)2
• Bifurcates at the terminus of the BVF2
• Arborizes towards the endplates2
Basivertebral Nerve Anatomy
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1Antonacci et al.2Bailey et al.
BVFBVN
Basivertebral Nerve Anatomy
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BVN Location
The BVF and the BVF Terminus are routinely seen on lumbar MR images
BVF
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Patient Criteria – Patient Indications
• Chronic Low Back Pain of at Least 6 Months Duration; and
• Failure to Respond to at Least 6 Months of Conservative Care; and
• MRI Demonstrated Modic Type 1 or Type 2 Changes at One or
More Levels From L3 to S1
• Note: Many Radiologists do not comment specifically on Modic
changes routinely
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Target Zone for Ablation
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Basivertebral nerve ablation zone: between
the anterior margin of the safety zone and
the BVF terminus. NOT in the safety zone.
10mm
10mm
Intracept®
Procedure Imaging
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Intracept® Procedure –Deployment
Deployment of Curved Cannula Assembly - Observe changing shape of tip
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Intracept® Procedure –Deployment
Final position of the Curved Cannula Assembly will vary from vertebra to vertebra
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Intracept® Procedure – Probe Deployment
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Final placement of the RF Probe
AP LAT
Intracept® Procedure –Review
After removing the Straight Stylet, insert the RF Probe, retract the PEEK Curved
Cannula, and ablate the target spot
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SMART Trial – Durable Improvement at 24 Month Follow-Up
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42.4
22.1 21.6 22.6
18.8
Baseline n=128
3 Months n=128
6 Months n=128
12 Months n=128
24 Months n=106*
6.73
3.80 3.743.96
3.13
Baseline n=128
3 Months n=127
6 Months n=126
12 Months n=125
24 Months n=104*
ODI VAS
54% Decrease at 24 Months 53% Decrease at 24 Months
*LOCF imputation used at all time points except 24 months where all observed data without imputation used
BVN Ablation Conclusion
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• Two Level I RCTs validate significant improvement in function and pain from baseline
• Highly significant treatment effect against standard care (p < 0.001) in INTRACEPT Study
• SMART Trial data supports durable results at 2 years*
• Adverse event profile and animal studies support safety
• No serious device related AEs; procedure AEs mild in severity
• No regeneration of nerve, no avascular necrosis, or biomechanical instability post-ablation
• Modic Changes have clinical implications
* Per ProtocolPopulation
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Intracept Procedure – Lesioning
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• Lesioning performed at 85ºC x 15 minutes
• MRI demonstrating post-ablation lesions
• Note location of each lesion
Intracept Procedure – Post-Lesioning
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6 weeks post-treatment 6 months post-treatment
Intracept Procedure – 6-Week Post-Lesioning
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Intracept Procedure – 6-Week Post-Lesioning
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T1 T2 STIR
Helping patients regain active and productive
lifestyles.
• Spinal stenosis is the result of aging and “wear and tear” on the spine from everyday activities. These changes cause the canals in the spine to narrow which can “pinch” the nerves in the lower back. This is called lumbar spinal stenosis (LSS). The result is pain, numbness, tingling and/or weakness in the back and legs.
VERTEBRAE
DISC
HEALTHY NERVE
PINCHED NERVE
SPINOUS PROCESS
DISC
VERTEBRAL BODY
SPINAL CANAL w/ STENOSIS
SPINOUS PROCESS
What is Spinal Stenosis?LIGAMENT
Clinical Presentation of Lumbar Spinal Stenosis
✓ Standing/walking provokes symptoms
✓ Pain/weakness in legs
✓ Patient lean forward while walking to move around more comfortably: “Shopping Cart Sign”
✓ Sitting (flexion) relieves symptoms
40
Traditional treatments for LSS
• Conservative Care (Non Surgical)• NSAIDs (Aspirin, Advil, Aleve, etc.)
• Epidural Steroid Injections
• Reduced Physical Activity
• Physical Therapy
Traditional Surgical Treatments
• Surgical Treatment Options• Laminectomy
• Laminectomy and Fusion
Bridging the Gap in the Continuum of Care
What is Superion®?
This device is implanted by minimally invasive methods through a small cannula.
Superion® is a spinal implant designed to treat symptoms of moderate lumbar spinal stenosis (LSS).
The Superion® procedure is reversible and will not remove the structures (bones or tissue) of the spine. All future treatment options will still be available.
Patients who will benefit the most from the Superion® implant are those whose symptoms are relieved when bending forward, such as when pushing a shopping cart.
VF-LD-0119-A
Neurogenic Intermittent Claudication (NIC)
©2019 Vertiflex, Inc. All rights reserved. | VF-LD-0117-DC 45
Canal and foraminal space for nerves increase in FLEXION
Canal and foraminal space for nerves decrease in EXTENSION
Superion restricts EXTENSION
Preventing extension reduces or eliminatesthe compression of nerves at the implanted level(s)
Procedural Flow
Physician gains access through a small incision in your lower back.
The implant that best fits your anatomy is delivered in a single step.
The surgical site is then closed.
Note: general anesthesia is not required for this procedure.
Procedural Flow
Patient’s Pre-Operative ImagingPre-Operative MRIs, Sagittal
Sagittal MRIs allow your physician to visualize your
spinal canal and look for any stenosis. This also helps
determine what the operative level should be.
2
Patient’s Pre-Operative ImagingPre-Operative MRIs, Axial L4/5
Axial MRIs (or top/bottom views of specific segments of your spine) allow your physician to determine the degree of central canal stenosis as well as any lateral or foraminal stenosis.
Patient’s Post-Operative Imaging
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For 6 weeks, limit all lifting, bending, and strenuous activity including:
• Lifting any weight over 10-15 lbs.
• Any large bending of the spine, especially twisting.
• Strenuous activity such as swimming, golf, tennis, racquet ball, running, jogging, or remodeling/RV projects
Increase your light activity, such as walking, as tolerated.
Post-operative care guidelines
Tracking Patient Satisfaction• The Superion® system offers a safe and effective alternative to other more invasive surgical
options, such as decompression or spinal fusion.
• It has been thoroughly tested for the treatment of leg pain symptoms associated with moderate spinal stenosis.
• The clinical trial was regulated by the FDA. 471 patients were enrolled in the trial.
• Among those patients in the clinical trial that were followed up through five years, almost all expressed overall satisfaction with the Superion® implant.
2 years 3 years 4 years 5 years
Physical Function 73% 80% 80% 81%
Symptom Severity 77% 84% 84% 75%
Patient Satisfaction 84% 92% 87% 90%
Highlights• Non disruptive
• Small incision
• Easily Reversible
• Does not require general anesthesia
• FDA Approved
Take back your life.
www.vertiflexspine.com866.268.6486
VF-LD-0119 Rev A
THE OMNIA™ SCS SYSTEMOne System. All Frequencies. Maximum Versatility.
• IPG can deliver or pair all frequencies between 2 -10,000 Hz
• Full body MRI conditionally approved
• Exclusively upgradeable to future waveforms and frequencies
• Programmer allows for the simple delivery of all approved frequencies in SCS, with the ability to easily pair the widest array of waveforms
• Includes new, intuitive patient accessories
Choose or Blend Your Mechanism of Action
For Direct Neural Inhibition, Frequency MattersResults of Preclinical Research into Frequency Effects on Nerve Types
• 10kHz frequency can drive inhibitory neurons without meaningfully activating excitatory neurons.
• This effect was not achieved at 1 or 5 kHz
Lee, Kwan et al. High Frequency kHz Spinal Cord Stimulation (SCS) Differently Affects Rodent Superficial Dorsal Horn Cell Types. NANS 2018.
Firin
g R
ate
(spik
es/s
)
1 kHz 5 kHz
Inhibitory Neurons
Excitatory Neurons
10 kHz
0
2
4
6
8
10
12
14
Neural Inhibition By Frequency
Omnia Case Study
Patient Profile
• Implant date: August 14, 2019
• Battery swap of SJM IPG; Omnia IPG with existing SJM perc leads at C2
• Pain areas: Predominately bilateral arm, shoulders, and upper extremities
Results
• Baseline pain score: 9
• Pain score at last follow up: 1.3
• Patient prefers frequency pairing (HF10 + LF) program
• Patient has been reporting 85%+ pain relief in upper extremities, arms, and shoulders since her battery was swapped. She is extremely active as she farms so after bailing hay for 8 hours a day, she enjoys switching over to tonic for a few hours as she reports it is a nice distraction and she doesn’t lose the pain relief that she has gotten in her upper extremities.
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Case courtesy of Leo Kapural MD PhD
The DRG: A collection of bipolar cell bodies of neurons surrounded by glial cells and the axons of the DRG sensory cells that form the primary afferent sensory nerve
The Dorsal Root Ganglion: Review of Anatomy
DRG
Ventral Dorsal
L4
L5
DRG
Image from: Hogan Q. Reg Anesth Pain Med. 2010.Image from: Gray’s Anatomy (2005). Standring, S. (Ed.).
SHEATH delivery
Neuromodulation – The FutureSpinal Cord Stimulation DRG
1. Deer et al, Neuromodulation 2014.2. Cameron T. J Neurosurg. 2004 3. Kim D, et al. Pain Physician. 2011
Thank you for your time!