CLASS#15 Sales Training Day 5 Assessment Practice Flashcards

Flashcards covering vertebral anatomy, lead implantation procedures, clinical study outcomes (B-Study, RESTORE), and patient identification for restorative neurostimulation.

What nerve is the primary target of stimulation by ReActiv8?

The medial branch of the dorsal ramus of $L2$

According to the Guven et al study, what was the primary aim regarding lumbar medial branch radiofrequency neurotomy (RFN)?

To assess the asymmetry in muscle morphology changes in patients undergoing unilateral RFN

How is the twelfth thoracic vertebra ($T12$) identified as a landmark?

It is the lowest of two vertebrae with floating ribs (ribs that do not attach to the sternum)

What is the primary mechanism of the Intracept procedure?

It ablates the basivertebral nerve to cut off endplate pain signals

What specific feature of the basivertebral nerve contributes to the durability of the Intracept procedure?

It is not myelinated and does not tend to grow back

What core problem does ReActiv8 address that Intracept does not?

Segmental instability due to poor multifidus control

For a standard ReActiv8 implant, what is the required lead and spare count?

$2$ leads per implant plus $2$ spares

Why is traceability for Class III devices considered a core requirement?

It allows identification of every implanted component and affected patient if safety or labeling changes

When should the initial IPG set up programming occur for an implant?

Before the patient is on the table

What is the positioning goal for reducing difficulty with imaging and needle placement?

Neutral, flatter lumbar lordosis

What are the five salient keys to a successful ReActiv8 procedure?

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

During lead fixation, how many times should the light tug test be performed?

$3$ to $4$ times

What actions are explicitly included in final confirmation testing at case completion?

$2\,Hz$ twitch test and electrode impedance measurements

What is considered the 'normal' impedance range in the implant and programming manual?

$150$ to $4999\,Ohms$

At what level should stimulation typically begin for intra-operative twitch testing?

$$1.0\,mA$$

According to the Ardeshiri et al. 'Older Patient' study, what percentage of the oldest quartile experienced a $50\%$ reduction in pain after two years?

$$62\%$$

In the Hodges et al. 'Sheep Study', which area of the multifidus showed the greatest reduction in fibrotic changes?

Stimulated muscle fascicles at $L4$

What indicator was used in the Hodges et al. study to analyze fibrosis in the multifidus?

Collagen-I and Collagen-III levels

Which three subsystems are involved in spinal stability?

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

In Phase I of Patient Identification, what criteria combine with Axial Back Pain to indicate Multifidus Dysfunction?

MRI Biomarker (Grade $2$ and $3$)

What are the three dysfunctional movement patterns identified in Phase II of Patient Identification?

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

Where is the midline incision placed during a ReActiv8 implant?

From the identified AP fascial entry point extending caudal approximately $3-4\,cm$

What percentage of patients in the ReActiv8-B Study became 'remitters' ($VAS \le 2.5\,cm$) at five years?

$$67\%$$

What is the ICD-10 code for 'Dysfunction of the multifidus muscles, lumbar region'?

$$M62.85$$

What was the primary endpoint of the RESTORE Trial?

Disability measured by ODI

In the ReActiv8-B Study at five years, what was the observed improvement in the Visual Analog Scale (VAS)?

$7.3$ to $2.4\,cm$

What was the average duration of back pain history for subjects in the RESTORE study?

$19$ years

What percentage of patients who used opioids at baseline in the ReActiv8-B study eliminated or reduced their use at five years?

$$69\%$$

Which radiographic scan type is commonly used to identify fatty infiltration in the Multifidus?

MRI

What are the documented components of the comprehensive ReActiv8 clinical evidence body?

$5$ years of follow-up, $5$ separate clinical studies, $567$ total patients, and $1800$ years of follow-up