ReActiv8 Sales Training Assessment Review

Flashcards covering the ReActiv8 Sales Training Assessment, including surgical procedures, clinical evidence (RESTORE and B trials), spinal anatomy, and sales methodology.

Vertebral Body

The structural component of the vertebra identified in anatomical diagrams of the lumbar spine.

Superior Articulating Process

A process that extends upward from the vertebra to articulate with the adjacent vertebra above it.

Inferior Articulating Process

A process that extends downward from the vertebra to articulate with the adjacent vertebra below it.

Transverse Process

A small bony projection off the right and left side of each vertebra.

Spinous Process

The bony projection off the posterior (back) of each vertebra.

Lamina

The part of the vertebral arch that connects the spinous process to the transverse processes.

Pedicle

The segment of bone that connects the vertebral body to the transverse process.

ReActiv8 Specialized Tines

Anchors used to secure leads by bracketing the intertransversarii muscle.

Intertransversarii Muscle

The specific muscle which ReActiv8 leads bracket using specialized tines for anchoring.

Medial Branch of the Dorsal Ramus of L2

The primary target nerve of stimulation for the ReActiv8 system.

T12 (Twelfth Thoracic Vertebra)

The vertebra sitting superior to $L1$ identified as the lowest of two vertebrae with floating ribs.

Floating Ribs

Ribs that do not attach to the sternum, used to identify the $T12$ vertebra.

Intracept Procedure

A procedure that ablates the basivertebral nerve to cut off endplate pain signals.

Basivertebral Nerve Myelination

A feature of the nerve that helps explain the durability of Intracept because the nerve is not myelinated and does not tend to grow back.

ReActiv8 Core Problem Address

Segmental instability due to poor multifidus control, which differentiates it from the Intracept procedure.

Ordering Stock in Advance

A best practice that protects the plan and reduces last-minute risk to the patient and physician.

Standard ReActiv8 Implant Lead Count

An implant consisting of $2$ leads plus $2$ spares.

Class III Device Traceability

A core requirement that allows identification of every implanted component and affected patient if safety or labeling changes occur.

Initial IPG Set Up Programming

A task that should occur before the patient is on the table during an implant.

Positioning Goal

To achieve a neutral, flatter lumbar lordosis to reduce downstream difficulty with imaging and needle placement.

Five Salient Keys to a Successful Procedure

Fluoroscopy alignment, fascial entry point, final delivery needle position, depth of lead placement, and strain relief loop.

Lead Fixation Tug Test

A light test performed approximately $3$ to $4$ times during lead fixation.

Final Confirmation Testing

A procedure explicitly including a $2Hz$ twitch test and electrode impedance measurements at implant completion.

Normal ReActiv8 Impedance Range

A range defined in the manual as $150$ to $4999\,Ohms$.

Top Left 4x4 Matrix Troubleshooting

The focus area for troubleshooting when an out-of-range value indicates a lead is plugged into port $1$ to $4$.

Intra-operative Twitch Stimulation Start

Stimulation that should typically begin at $1.0\,mA$.

Guven et al. Study Primary Aim

To assess the asymmetry in muscle morphology changes in patients undergoing unilateral lumbar medial branch radiofrequency neurotomy (RFN).

Fluoro Image Alignment Landmarks

The pedicles and spinous process of $L3$ which should be aligned/centered prior to placing guide needles.

Guidewire Posterior/Upward Deflection

An indicator that the intertransversarius structure has not been fully penetrated due to insufficient delivery needle advancement.

Ardeshiri et al. "Older Patient" Study Result

$62\%$ of the oldest quartile experienced a $50\%$ reduction in pain after two years of restorative neurostimulation.

Lumbar Spine Proprioception

Regulation of spinal position, movement, and stability through perception or awareness.

Hodges et al. "Sheep Study" Stimulation Area

Stimulated muscle fascicles at $L4$ showed the greatest reduction in fibrotic changes due to neurostimulation.

Multifidus Muscle Role

The primary segmental stabilizer muscle of the lumbar spine.

ReActiv8 B Trial Robustness Factors

A blinded randomized sham-controlled trial including a variety of degenerative pathologies and reporting outcomes to $5$ years.

Mainstay Medical Patient Activation Items

User Manual with ID/Implant Card, Activator, and Magnet.

ReActiv8 Electrode Length

A length of $3\,mm$.

[R]eframe Step Outcome

Agreement that multifidus dysfunction is a plausible and testable driver of mechanical low back pain.

Phase II Patient Identification Dysfunctional Patterns

Instability or Weakness, Flexion with Light Load, and Positional Transitions.

Patented Tines Location

Located on the distal and proximal sides of the first electrode of each ReActiv8 lead.

Midline Incision Placement

A 3-4 cm incision extending caudal from the identified AP fascial entry point.

ODI Improvement Consistency (1 Year)

$70\%$ improvement in the RESTORE trial compared to $69\%$ in the ReActiv8-B trial.

Multifidus Lift Test (MLT)

A physical examination test that detects pain when motions are initiated.

RESTORE Subjects Average Age

An average age of $51$ years old.

RESTORE Subjects CLBP History

An average history of $19$ years of chronic low back pain.

Nociceptive Pain

Pain caused by injury or stress on non-neural tissues such as bones, ligaments, and muscles.

Hodges Sheep Study Fibrosis Primary Indicator

The levels of Collagen-I and Collagen-III used to analyze fibrosis in the multifidus muscle.

Three Subsystems of Spinal Stability

Muscles (active), brain (neural), and spine (passive).

Medial

Towards the midline.

Distal

Farther from a reference point or extremity.

Superior

The upper part or above a specific location.

Proximal

Closer to a point of reference or extremity.

Inferior

The lower part or below a specific location.

Lateral

Away from the midline.

Complaint Submission: Who

Requirement to specify who was affected by the incident.

Complaint Submission: What

Requirement to specify what happened in the incident.

Complaint Submission: When

Requirement to specify when the incident happened.

Complaint Submission: Where

Requirement to specify where the incident happened.

Complaint Submission: Product Identifiers

Requirement to provide the Part #, Serial #, or Lot #.

Altered Neuromuscular Control Presentation

The offloading of control to the superficial core (erector spinae) and multifidus dysfunction/atrophy.

ReActiv8-B Remitter Percentage (50% Pain Reduction)

$72\%$ of patients at five years in the ReActiv8-B study.

Prone Instability Test (PIT) Action

Activates the posterior spinal musculature to emulate gross spinal stability.

ReActiv8 B Trial Observed Pathologies

Grade 1 spondylolisthesis, endplate modic changes, and facet arthropathy.

Oswestry Disability Index (ODI) Range

Measures the extent to which a person's functional level is restricted by disability.

Phase I Patient Identification Framework

The combination of Clinical History, MRI Biomarker, and Axial Back Pain.

Visual Analog Scale (VAS) Description

A pain scale comprised of a $10\,cm$ line.

Three Most Important Functions of the Spine

Structural support, protection of the spinal cord/roots/internal organs, and flexibility/mobility.

RESTORE Trial Total Patients

$203$ total patients across $25$ clinical sites.

Multifidus Radiologic Scan Type

MRI, commonly used to identify fatty infiltration.

Neuropathic Pain

Pain caused by disease or damage to the nerve tissue.

Multifidus Contraction Characteristics

Anticipatory control of intervertebral motion, slow twitch (Type I) fibers, and sub-max sustained effort at $10-25\%$ of maximum contraction.

Sales Process Definition

A structured, step-by-step sequence of activities guiding from first contact through to close.

Reframe Step (Sales)

Inviting the physician to consider low back pain through a new lens of multifidus dysfunction.

Elevate Awareness Step (Sales)

Broadening the perspective beyond short-term pain relief to see the deeper issue of multifidus dysfunction.

Align Step (Sales)

Building empathy and urgency by aligning around the downstream effects of current approaches.

Create New Vision Step (Sales)

Jointly imagining what a more durable solution would look like.

Transition to Therapy Step (Sales)

Introducing ReActiv8 as the enabling solution that fulfills the new vision.

Incorporate Step (Sales)

Operationalizing adoption with clear roles, tools, and processes.

Validate Step (Sales)

Demonstrating impact through patient stories and measured results.

Acceler8 Step (Sales)

A stage in the ReActiv8 methodology associated with confirming results.

CLBP Nociceptive Nature

Observation that approximately two-thirds of chronic low back pain is predominantly nociceptive.

ReActiv8 Therapy Schedule

A recommended schedule of thirty minutes twice daily initiated by the patient.

Proprioception

The perception or awareness of the position and movement of the body.

Sales Methodology Definition

The set of principles, skills, and best practices that inform how a salesperson executes each step of the sales process.

Neuromuscular Control Loss Pattern

Repeated occurrences of adverse symptoms over time which become longer and more disabling.

REACTIV8 Sales Methodology behaviors

Teach, Tailor, and Take Control.

Yadav et al. RF Ablation Trend

A reduction of responders over time from $72\%$ at 1-month to approximately $24\%$ at 1-year.

Primary Endpoint of RESTORE

Disability measured by ODI.

Primary Endpoint of ReActiv8 B Study

Comparison of sham and active treatments at $120$ days in low back pain VAS.

RESTORE ODI Delta

A $-16.8$ point difference between the OMM group and the ReActiv8 group.

ReActiv8 Safety Profile

Demonstrated to be equivalent to or better than current standard neuromodulation techniques.

Facet Joint Innervation

Innervated by the same nerve that innervates the multifidus muscle.

B Study 5-Year ODI Reduction ($\ge 20$ points)

$61.1\%$ of patients reported this reduction in the ReActiv8 B study at five years.

B Study Pathology Incremental Success

Patients with Modic Changes did incrementally better than others.

Guven et al. RFN Morphology Results

A greater increase in fatty infiltration and decrease in functional cross-sectional area on the RFN side.

ICD-10 Code M62.85

The code for 'Dysfunction of the multifidus muscles, lumbar region'.

Multifidus Proprioceptive Receptors

Muscle spindles rich in receptors essential for detecting changes in muscle length and tension.

B Study 5-Year VAS Improvement Mean

A VAS improvement from $7.3$ to $2.4\,cm$.

B Trial Average Pain Duration

An average of $14$ years of pain history.

Average Observed MRI Pathologies (B Trial)

$2.3$ pathologies per participant.

B-pivotal Trial 5-Year Completion Count

$126$ participants completed the five-year follow-up.