February 22, 2020 10:45am ADVANCES IN PAIN MANAGEMENT...a path to treatment location ... System for the relief of chronic low back pain RelievantConfidential. RelievantConfidential

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


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


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


30MPeople Living with

Chronic Low Back Pain in US

900KNew Incidences of Patients with

Chronic Low Back Pain in US

Navigant Research Report


• 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


• Asymptomatic lumbar DDD in 57% of adults

• Asymptomatic lumbar DDD in 93% of adults > 60

years of age

Boden et al.


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



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


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


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


1Antonacci et al.2Bailey et al.

BVFBVN

Basivertebral Nerve Anatomy


BVN Location

The BVF and the BVF Terminus are routinely seen on lumbar MR images

BVF


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


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


Intracept® Procedure –Deployment

Deployment of Curved Cannula Assembly - Observe changing shape of tip


Intracept® Procedure –Deployment

Final position of the Curved Cannula Assembly will vary from vertebra to vertebra


Intracept® Procedure – Probe Deployment


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



SMART Trial – Durable Improvement at 24 Month Follow-Up


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


• 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


Intracept Procedure – Lesioning


• Lesioning performed at 85ºC x 15 minutes

• MRI demonstrating post-ablation lesions

• Note location of each lesion

Intracept Procedure – Post-Lesioning


6 weeks post-treatment 6 months post-treatment

Intracept Procedure – 6-Week Post-Lesioning


Intracept Procedure – 6-Week Post-Lesioning


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

50

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

[email protected]

VF-LD-0119 Rev A

http://www.vertiflexspine.com/

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.

Powered by NevroCloud™

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!

Documents

February 22, 2020 10:45am ADVANCES IN PAIN MANAGEMENT...a path to treatment location ... System for the relief of chronic low back pain RelievantConfidential. RelievantConfidential