Coblation^® (ArthroCare Corporation, Sunnyvale, CA) is a type of radiofrequency ablation referred to as cold or controlled ablation. Coblation^® devices direct radiofrequency energy, rupturing target tissue cells and disintegrating molecules with minimal heat production. Coblation^® technology can be delivered by a variety of wands, hand pieces and stylette tips used at different anatomic sites. Coblation^®-based wands such as the TOPAZ^® Microdebrider (ArthroWands^®_,ArthroCare Corporation, Sunnyvale, CA) are used for debridement, decompression, and removal of soft tissue during minimally invasive arthoscopic procedures involving tendons in the ankle and foot, elbow, hip, knee, shoulder, and wrist.

This document addresses the use of Coblation^® for the treatment of musculoskeletal conditions.

Note: Please see the following documents for other proposed uses of Coblation^® technology or other related indications:

• MED.00054 Treatment for Obstructive Sleep Apnea in Adults
• SURG.00071 Percutaneous and Endoscopic Spinal Surgery
• SURG.00100 Cryoablation for Plantar Fasciitis and Plantar Fibroma

Investigational and Not Medically Necessary:

The use of Coblation^® technology is considered investigational and not medically necessary for the treatment of musculoskeletal conditions.

Currently, there are no randomized controlled trials in the medical literature demonstrating the efficacy of Coblation^® technology and related devices for treatment of joint or musculoskeletal soft tissue conditions. The available studies are nonrandomized small case series reporting short-term outcomes (Tasto, 2005). Further prospective, randomized studies with large sample sizes reporting long-term outcomes are needed to demonstrate the safety and efficacy of this approach compared to established methods of management of musculoskeletal conditions.

In 2008, the ArthroCare Corporation completed collection of primary outcome data for a prospective double-blind randomized controlled study using the TOPAZ^® MicroDebrider Coblation^®-based fasciotomy as treatment for recalcitrant plantar fasciitis and plantar fasciosis (U.S. NIH, 2008). The study evaluated the effectiveness of the device for providing pain relief and benefits such as reduced incidence of postoperative complications and improved function. The results of this study are currently unpublished in the peer-reviewed medical literature.

Coblation^® is a form of bipolar radiofrequency energy technology in which the current does not pass directly into the tissue therefore producing minimal thermal injury to surrounding tissues. The mechanism of action involves combining bipolar radiofrequency energy with a conductive solution such as gel or saline. An electrode wand device forms a vapor that subsequently breaks down, producing ions in a gas plasma layer. The formed reactive plasma particles are able to break molecular bonds within the targeted tissue. The ArthroCare Corporation has created Coblation^® devices for intraoperative use to assist with hemostasis in a number of surgical settings including cosmetic, urology, spine and neurology, ear, nose and throat, gynecology, and laparoscopy/general surgery. 

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to ArthroCare TOPAZ^® ArthroWands^® as a Class II arthroscope (HRX), electrosurgical cutting and coagulation devices (GEI) (FDA, 2006). Commercially available Coblation^® devices (ArthroCare Sports Medicine) include a broad range of surgical wands used by orthopedic surgeons to perform minimally invasive arthroscopic procedures to the ankle and foot, elbow, hip, knee, shoulder, and wrist involving soft tissue debridement, subacromial decompression, meniscal removal and sculpting, or tendon debridement.

Bipolar radiofrequency: A radiofrequency device that contains both the active and return electrodes in the probe.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Khan AM, Fanton GS. Thermal energy in the knee. Techniques in knee surgery. 2004; 3(3):180-186.
2. Levine MJ, Shaffer B. Basic science applications of thermal energy in arthroscopic surgery. Sports Med Arthro Rev. 2005; 13(4):186-192.
3. Owens BD, Stickles BJ, Balikian P, Busconi BD. Prospective analysis of radiofrequency versus mechanical debridement of isolated patellar chondral lesions. Arthroscopy. 2002; 18(2):151-155.
4. Sherk HH, Vangsness CT, Thabit G III, Jackson RW. Electromagnetic surgical devices in orthopaedics. Lasers and radiofrequency. J Bone Joint Surg. 2002; 84-A(4):675-681.
5. Tasto JP, Cummings J, Medlock V, et al. Microtenotomy using a radiofrequency probe to treat lateral epicondylitis. Arthroscopy. 2005; 21(7):851-860. 

Government Agency, Medical Society, and Other Authoritative Publications:

1. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. ArthroCare^® Topaz™ ArthroWands^® Device Summary. No.K053567. Rockville, MD: FDA. March 6, 2006. Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm. Accessed on November 22, 2010.
2. U.S. National Institutes of Health; ArthroCare Corporation. Plantar fasciosis treatment using coblation. NLM Identifier: NCT00189592. Last updated July 31, 2008. Available at: http://clinicaltrials.gov/ct/gui/show/NCT00189592. Accessed on November 22, 2010.

ArthroWand^®
Atlas^TM System Controller
Bipolar Radiofrequency Electrosurgery
Coblation^®
Cold Ablation
Non-Thermal Volumetric Tissue Reduction
Plasma-induced RF
Radiofrequency Ablation (RF)
Short Bevel
TOPAZ^® EPF MicroDebrider 45
TOPAZ^® Microdebrider with Integrated Finger Switches (IFS)
TOPAZ^® ICW
TOPAZ^® XL ICW

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.