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SIMPLICITY™ PROBE

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OUR MULTI-ELECTRODE RADIOFREQUENCY (RF) PROBE

Enter a new era of performing RF ablation with our Simplicity™ Probe. A self-contained, patented SI denervation solution,1,2 the Simplicity Probe features three independent active areas to generally reduce procedure time2. It is designed for denervation of the sacroiliac region, including peripheral nerves at S1–S43. You will not need an introducer. 

 

This device is commercially available for use in select international markets.

DESIGNED FOR REDUCED PROCEDURE TIME2

The Simplicity RF Probe features three independent, active electrodes that create a true strip lesion from a single insertion point2:

  • Designed to create a continuous ablation strip with no gaps
  • Ergonomic handle enhances maneuverability
  • Flexibility to create a smaller lesion by activating only the distal and medial electrodes
  • Designed to be flexible enough to facilitate placement in difficult-to-navigate anatomical areas

Simplicity Probe electrodes

EXPAND YOUR TREATABLE PATIENT POPULATION

The Simplicity RF Probe is part of Abbott’s evolving portfolio of RF therapy technologies. Our vision is to transform the management of chronic pain by advancing RF therapy through clinical research and education and designing for procedural efficiencies for more options to treat more patients. Read more about managing chronic pain and where RF therapy may fit into an effective treatment approach.

RESOURCES AND DOCUMENTATION

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Reorder Number Description

RFDE-SI

Simplicity™ Denervation Probe

 

ACCESSORIES

Reorder Number Description

AC-SI-III

NT1100™ and NT2000iX™ Generator to Simplicity™ Denervation Probe

QUESTIONS ABOUT REIMBURSEMENT?

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References:

1. Simplicity is protected under US Patent US8323277 B2.
2. Schmidt PC, Pino CA, Vorenkamp KE. Sacroiliac joint radiofrequency ablation with a multilesion probe: A case series of 60 patients. Anesthesia & Analgesia. 2014. 119(2), 460–462.
3. Simplicity™ III Disposable Radiofrequency Electrode Clinicians’s Manual. Plano, TX. 2019.

 

IMPORTANT SAFETY INFORMATION

Simplicity™ III Disposable Radiofrequency Electrode

Indication for Use

The Abbott Medical Simplicity™ III Disposable Radiofrequency Electrode is intended for use in the treatment of chronic pain by the ablation of neural tissue.

Description

The Simplicity III electrode is a disposable radiofrequency (RF) device consisting of three isolated electrodes along the shaft. Radiopaque markers are located between the distal and the middle electrodes, between the middle and the proximal electrodes, and below the proximal electrode. These radiopaque markers clearly show the separation of the three electrodes under X-ray.

Warnings

  • Sharp; handle carefully.
  • Do not proceed unless all electrodes read body temperature when connected and inserted into the patient.
  • Stop if heat is felt at site of the grounding pad.
  • When the Simplicity III electrode is used to perform lesion procedures in the sacral region, always ensure that the electrode does not enter any of the sacral foramen and that the electrode does not proceed inferior to the inferior border of the sacrum.
  • Do not use the electrode if the package has been opened or damaged.
  • Ensure the most proximal contact on the electrode is not too close to the dermis to prevent skin burn.
  • Use of general anesthesia is not recommended during the procedure. It is advised to use local anesthesia or conscious sedation so patient interaction is possible.
  • The electrode should only be used by physicians trained in the use of the device.
  • The electrode is intended for single-use only. This device is not intended for bilateral use.
  • The electrode should only be used with an Abbott Medical RF generator.
  • During treatment with the Simplicity III electrode, the patient should continuously be monitored and evaluated for any unexpected symptoms.
  • Before starting any thermal treatment with the electrode, ensure no motor nerves are in the vicinity of the electrode.
  • Do not move the electrode while it is activated.
  • Do not use the electrode if any damage is observed.
  • Do not bend or reshape the electrode; this can cause permanent mechanical damage.
  • Use minimal force and torque when manipulating the electrode; the handle has been designed to release if too much torque is applied. 
  • Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness, or death of the patient.
  • Reprocessing may compromise the structural integrity of the device and/or lead to device failure.
  • Cleaning, disinfection, and sterilization may compromise essential material and design characteristics, leading to device failure.

Directions for Use

  1. Place the Simplicity™ III electrode so that the three active contacts are in the desired anatomical position. A sterile adapter cable is needed to activate the electrode.
  2. Connect the adapter cable to the RF generator by matching each of the three connectors to the corresponding receptacles. (Insert connector 1 to receptacle 1; connector 2 to receptacle 2, and connector 3 to receptacle 3.)
  3. Connect the opposite end of the adapter cable to the electrode. Refer to the RF generator Instructions for Use and Addendum v.3.05 or later for Simplicity RF procedural settings and steps.

To use the RF generator / Simplicity III procedure functionality, AUTO DISPERSIVE must be on. To activate:

  1. On the Welcome screen, press OPTIONS.
  2. Press MORE.
  3. Press AUTO DISPERSIVE.
  4. Press ON.
  5. Press FINISH.

Handling and Storage

The Simplicity III electrode is provided in a sterile package. This should not be bent or folded as this may cause product and/or packaging damage. The electrode should be stored in a cool and dry place; avoid exposure to extreme temperatures. The Instructions for Use is recyclable. Dispose of all packaging materials as appropriate. Dispose of products and accessories per standard solid biohazard waste procedures.

 

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