Medical Policy

 

Subject: Percutaneous Ultrasonic Ablation of Soft Tissue
Document #: SURG.00149 Publish Date:    06/06/2018
Status: Reviewed Last Review Date:    05/03/2018

Description/Scope

This document addresses the use of percutaneous ultrasonic ablation (emulsification) of soft tissue for the treatment of any condition.

Note: Please see the following related documents for additional information:

Note: This document does not address the use of high intensity focused ultrasound (HIFU) ablation for any indication. For information regarding HIFU ablation, please see the following documents:

Position Statement

Investigational and Not Medically Necessary:

Percutaneous ultrasonic ablation of soft tissue is considered investigational and not medically necessary for the treatment of any condition, including, but not limited to any of the following musculoskeletal conditions:

  1. Achilles tendinosis; or
  2. Lateral or medial elbow tendinosis; or
  3. Patellar tendinosis; or
  4. Recalcitrant plantar fasciitis; or
  5. Rotator cuff or shoulder tendinosis.
Rationale

Percutaneous ultrasonic ablation is a minimally invasive surgical procedure proposed for use in the fragmentation, emulsification, and aspiration of soft tissue associated with any condition, including chronic or degenerative conditions of the musculoskeletal system involving fascia or tendons of the ankle, foot, elbow, hip, knee, shoulder, or wrist. In March 2013, the TX1 Tissue Removal System (Tenex Health, Inc., Lake Forest, CA) received U.S. Food and Drug Administration (FDA) 510(k) clearance (K12364) as “an ultrasonic surgical aspirator” to emulsify and remove soft tissue. In March 2016, the Tenex Health TX® System (K153299) (Tenex Health, Inc., Lake Forest, CA) received 510(k) clearance as substantially equivalent to the predicate device, the TX1 Tissue Removal System. Both systems are intended for use with a TX2 MicroTip in “surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable.” The FDA 510(k) clearance regulates these devices as “unclassified”; in addition, the FDA’s Indications for Use Statement for each device does not specifically describe their intended use in surgical procedures involving partial or complete surgical cutting (transection) or division of fascia (fasciotomy) or tendons (tenotomy) (FDA, 2016).

There is currently a lack of evidence in the peer-reviewed medical literature in the form of randomized, double-blind controlled trials demonstrating the efficacy and safety of percutaneous ultrasonic ablation of soft tissue using minimally invasive devices for the treatment of any condition, including, but not limited to chronic conditions of the musculoskeletal system (for example, fasciopathy or tendinopathy).

Barnes and colleagues (2015) reported a case series of 19 subjects treated with percutaneous ultrasonic ablation for chronic elbow tendinosis. Subjects with greater than 6 months of conservative management for chronic medial (n=7 subjects) or lateral (n=12 subjects) elbow tendinosis were offered the TX1 Tissue Removal System procedure as one of several treatment options. All subjects were evaluated using visual analog scale (VAS) pain score (range, 0-10; lower score is “better”), the Quick Disabilities of the Arm, Shoulder and Hand (Q-DASH) 11-item score (range 0-100; lower score is “better”), and the Mayo Elbow Performance Score (MEPS, range, 0-100; higher score is “better”) on the day of treatment and at 6 weeks posttreatment. Additional VAS, Q-DASH, and MEPS scores were obtained by mail responses from subjects at 3, 6, and 12 months after treatment. The mean VAS pain scores were reported as significantly improved from baseline (VAS, 6.4) compared to 6 weeks (VAS, 2.6), 3 months (VAS, 0.9), 6 months (VAS, 1.7), and 12 months (VAS, 0.7) after treatment (p<0.0001). The majority of improvement in VAS pain score was reported during the first 3 months postprocedure, with VAS scores improving significantly between pretreatment and 6 weeks posttreatment and between 6 and 12 weeks posttreatment; thereafter, VAS scores remained statistically unchanged (that is, between 3 months and 12 months posttreatment). Improvement in Q-DASH scores and MEPS values were similar when compared to VAS scores at pre- and posttreatment measurements (p<0.0001). No procedure-related complications occurred in any subject during the 12-month follow-up period. Limitations of this case series include the small sample size, lack of a control group, subject-reported outcomes (by mail) at 3, 6, and 12 months after treatment, and lack of direct comparisons to other interventions used in the treatment of chronic lateral or medial elbow tendinopathy.

Koh and colleagues (2012) reported on the safety, tolerability, and efficacy of percutaneous ultrasonic ablation of degenerative tendon tissue using the TX1 Tissue Removal System in an open-label case series of 20 subjects who failed nonoperative therapy for a minimum of 3 months for recalcitrant lateral elbow tendinopathy. Outcome parameters included procedure- and device-related complications, VAS pain scores, DASH scores at 1, 3, 6, and 12 months, radiological documentation in the form of postprocedural ultrasound assessment of the elbow at 3 and 6 months, and patient satisfaction indicators. There were no reported procedure- or device-related adverse events. A significant improvement in the median VAS score occurred from baseline to 1 week postprocedure (5.5 to 3.3; p<0.001), with further improvement at 3, 6, and 12 months from baseline (from 2.0 to 1.0 to 0.50, respectively; p=0.003 and 0.023). Significant improvements in both DASH-Compulsory (from 21.7 to 11.3; p=0.001) and DASH-Work scores (from 25.0 to 6.3; p=0.012) occurred by 1 month. The DASH-Compulsory score improved significantly from 3 to 6 months (from 8.6 to 4.6; p=0.003), and both the DASH-Compulsory and DASH-Work scores were sustained by 12 months. A total of 19 of 20 subjects (95%) expressed satisfaction with the procedure at 6 months: 9 subjects were very satisfied, 10 subjects were somewhat satisfied, and 1 subject was neutral. By 6 months, ultrasonography findings identified reduced tendon thickness in 19 of 20 subjects (95%), resolved (n=10) or reduced (n=7) hypervascularity in 17 subjects, and reduced hypoechoic lesions in 18 subjects. Limitations of this case series include the small sample size, lack of a control group, and lack of blinding to treatment. The authors noted that “it is well recognized that elbow tendinopathy is a self-limiting condition and can also be subject to placebo effects of perceived therapeutic procedures.”

Seng and colleagues (2016) reported on 3-year outcomes of percutaneous ultrasonic ablation for recalcitrant lateral elbow tendinopathy using the TX1 Tissue Removal System. All 20 subjects from the Koh case series (2013) were reassessed at 36 months after the procedure in all outcome parameters. Sustained improvement was reported in VAS pain scores (pain relief) and DASH-Work scores, and further reduction was reported in DASH-Compulsory scores to a median of 0 ± 0.644 with a significant decrease on repeated measures (p=0.008). At 36 months, all 20 subjects exhibited reduction in tendon thickness, 17 of 20 subjects (94.4%) achieved complete resolution of hypervascularity, and 4 of 20 subjects (20%) had complete resolution of hypoechoic lesions.

In an industry-sponsored case series, Patel (2015) provided a detailed description of the TX1 Tissue Removal System to partially release plantar fascia lesions in 12 subjects (mean duration of symptoms, 19 months) who failed conservative care including physical therapy, casting, injections, and other invasive procedures such as endoscopic partial release for refractory plantar fasciitis. Of the 12 subjects, 4 subjects were previously treated with an open or endoscopic partial release with no improvement in symptoms. Pre- and postoperative subjective and objective health outcomes were evaluated using the American Orthopaedic Foot and Ankle Society (AOFAS) Scoring Scale to measure pain, function, and alignment (total score, 100 points). Subjects had a mean preoperative AOFAS score of 30 (range, 17-46) and a mean postoperative score of 88 (range, 25-92). A total of 11 subjects reported resolution of symptoms, that is, no activity restricted by plantar fascia pain, by the 3-month postoperative visit. Pain relief was documented as occurring between 5 weeks and 13 weeks after treatment. There were no postoperative infections or wound complications. Limitations of this case series are the small sample size, single-surgeon experience, lack of a control group, and short-term outcomes.

Sanchez and colleagues (2017) reported on complications similar to those following Achilles tendon surgery in 6 subjects treated with percutaneous ultrasonic ablation with the TX1 Tissue Removal System for chronic Achilles tendinosis or heel pain. Four of the 6 subjects were active sports participants (including, cycling, ultra distance running, or marathon runners). Complications following percutaneous ultrasonic ablation included longitudinal and transverse tearing of the tendon, deep vein thrombosis, sudden onset of popping in the surgical area with searing pain (6 weeks postoperative), and sudden, sharp pain with chronic tearing. The authors expressed concerns with the efficacy and safety of the procedure for Achilles tendinosis, stating that percutaneous ultrasonic ablation with ultrasound visualization should allow the surgeon to visualize the pathologic portion of the Achilles tendon. However, “in reality, ultrasound scanning delivers a 2-dimensional image of a 3-dimensional structure. This leaves surgeons with 1 of 2 scenarios: removing too much healthy tendon or failing to remove all the pathologic tendon.” Another concern with the procedure (and as observed in the study subjects) is that the pistoning motion of the cutting handpiece may penetrate healthy tendon due to inadequate visualization provided by the ultrasound probe. Transverse cuts could be seen, in addition to the longitudinal, chronic tearing of the Achilles tendon, leading to “stagnation of symptoms or worsening of the Achilles tendinosis. The healing potential and vascularity of the Achilles tendon are baseline concerns with Achilles tendon pathologic entities, in general, and the use of PUT can potentially increase this risk.” The authors concluded that “because of the severe lack of published data backing up its use, we would recommend against the use of PUT to treat Achilles tendon issues or, at the least, consider its use similar to that of surgery.” Nonsurgical interventions should be tried before surgical intervention, including physical therapy, foot orthoses, heel cushions, and eccentric strengthening.

In summary, while short-term results from a limited number of small case series report early positive outcomes in reduction of pain and improvement in physical function, further investigation is needed to determine if percutaneous ultrasonic ablation with devices such as the TX1 Tissue Removal System or Tenex Health TX System can sustain functional improvement and eliminate or reduce pain in individuals with chronic or recalcitrant conditions of the soft tissue. Well-designed prospective, randomized controlled trials comparing percutaneous ultrasonic ablation to standard treatments are needed to determine if spontaneous improvement without the procedure can be excluded and if a durable treatment effect can be established over placebo.

Other Considerations

The American Medical Society for Sports Medicine (AMSSM) has published a position statement on the use of interventional musculoskeletal ultrasound in sports medicine (Finnoff, 2015). Ultrasound-guided surgical techniques, such as percutaneous ultrasonic ablation of soft tissue that use specialized devices, are described as “third-generation techniques” for musculoskeletal conditions, and will likely “be adopted” in the near future.

Background/Overview

Description of the Conditions

Soft tissue conditions of the musculoskeletal system include, but are not limited to, acutely inflamed or chronic conditions of the fascia or tendons. Treatment of these conditions, particularly tendinopathies, is dependent on confirmation of the distinct diagnosis of tendinitis versus tendinosis. Tendinitis is described as an acutely inflamed and swollen tendon without microscopic tendon damage. In contrast, tendinosis is a clinically damaged tendon with disorganized fibers and a hard, thickened, scarred and rubbery appearance. The underlying cause of tendinosis is degeneration. Tendinosis is chronic and occurs in the Achilles tendon, extensor tendon of the elbow (tennis elbow), gluteal tendons on the outside of the hip, the patellar tendon, and the rotator cuff tendons of the shoulder. Standard treatment for tendinosis may include rest, non-steroidal anti-inflammatory drugs, braces, splints and straps, physical therapy, or injection therapy.

The plantar fascia is a wide ligament-like structure that covers the bottom of the foot, extending from the heel bone to the base of the toes. This band of thick tissue protects the bottom of the heel bone and acts like a shock absorber for the bottom of the foot. In many individuals, the plantar fascia may become irritated, causing a condition called plantar fasciitis. This is the most common cause of heel pain. The cause of this condition is not entirely clear, but is associated with or due to repetitive trauma. It is common in several sub-groups of people, including runners and other athletes, people who have jobs that require a fair amount of walking or standing (especially if it is done on a hard surface), and in some cases it is seen in people who have put on weight, including through pregnancy. Most people who have plantar fasciitis recover with conservative treatments with use of pain relievers (such as, ibuprofen or naproxen to ease pain and inflammation), physical therapy (stretching and strengthening exercises), night splints, and over-the-counter orthotics (such as, heel cups, cushions, or custom-fitted arch supports). Approximately 75% of individuals recover after 6 months and up to 98% after 12 months. In cases where plantar fasciitis is chronic and resistant to conservative treatments, surgical intervention may be indicated to treat the fibrous tissue that develops at the plantar fascia attachment resulting from long-standing inflammation.

Description of the Technology

The TX1 Tissue Removal System and the Tenex Health TX System are ultrasonic surgical aspirators that irrigate, fragment, emulsify and aspirate soft tissue and are proposed for use in the treatment of recalcitrant tendinopathy or plantar fasciopathy. The Tenex Health TX System is identical to the predicate TX1 Tissue Removal System in its mode of operation and FDA-cleared indications for use. Only minor technological differences are noted when comparing the device systems, in that the predicate device TX1 MicroTip needle and molded polycarbonate case nose were modified with the TX2 MicroTip model, and, the predicate TX1 Tissue Removal System includes an additional coagulation function not available with the Tenex Health TX System. Each device functions under sonographic guidance to debride and aspirate degenerative soft tissue seen in tendinopathy or fasciopathy. According to the 510(k) summary for the Tenex Health TX System (K153299), the system consists of a console, ultrasonic handpiece, inflation cuff and foot pedal. The console provides control over the user functions including irrigation, aspiration, and ultrasonic fragmentation/emulsification and has a large, color LCD monitor with a touch-screen and a graphical user interface for selection of required settings. The ultrasonic handpiece connects to the console for power, as well as for delivering irrigation fluid directly to the surgical site and for aspirating emulsified tissue by way of an integrated tubing set. The foot pedal is used to control each of the functions (irrigation, aspiration, ultrasonic fragmentation/emulsification) of the system. The console may be used with the predicate device TX1 MicroTip or the modified TX2 MicroTip (FDA, 2016).

Percutaneous ultrasonic surgical devices debride and ablate (remove) the degenerative soft tissue under local anesthetic. A stab incision creates an entry site for the blunt tip of the device. The device is advanced under sonographic guidance into the lesion where it is activated using a foot pedal to irrigate, fragment, emulsify and aspirate the involved soft tissue lesion(s). The device may need to be redirected to cover the entire area of the lesion (as identified by ultrasound) until the degenerative tissue is completely treated. Following the procedure, wound closure is accomplished using a sterile dressing. Postprocedural activity restrictions and the need for a conservative rehabilitation program depend on the site being treated and the extent of the preoperative condition. The procedure is reported as being performed in the physician’s office or an ambulatory surgery setting (Barnes, 2015; Peck, 2016).

Definitions

Tendinitis (or tendonitis): An acutely inflamed swollen tendon that does not have microscopic tendon damage. Tendinitis results from chronic inflammation of the tendon when it is overloaded with a tensile force that is too heavy and/or too sudden.

Tendinosis: A chronically damaged tendon with disorganized fibers and a hard, thickened, scarred and rubbery appearance. The underlying cause in tendinosis is a degeneration of the tendon’s collagen in response to chronic overuse, such as with repetitive strain injury.

Tendon: A tough cord or band of dense fibrous tissue that connects a muscle to some part of a bone.

Tenotomy: The surgical cutting or division of a tendon for relief of a deformity caused by congenital or acquired shortening of a muscle, as in clubfoot or strabismus.

Coding

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:
For the following procedure codes; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

17999

Unlisted procedure, skin, mucous membrane and subcutaneous tissue [when specified as percutaneous ultrasound ablation of subcutaneous tissue]

20999

Unlisted procedure, musculoskeletal system, general [when specified as percutaneous ultrasonic ablation of soft tissue]

 

Note: if a tenotomy or fasciotomy code is used to represent percutaneous ultrasonic ablation, the procedure is considered investigational and not medically necessary.

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Barnes DE, Beckley JM, Smith J. Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study. J Shoulder Elbow Surg. 2015; 24(1):67-73.
  2. Koh J, Mohan P, Howe T, et al. Fasciotomy and surgical tenotomy for recalcitrant lateral elbow tendinopathy: early clinical experience with a novel device for minimally invasive percutaneous microresection. Am J Sports Med. 2012; 41:636-644.
  3. Patel MM. A novel treatment for refractory plantar fasciitis. Am J Orthop (Belle Mead NJ). 2015; 44(3):107-110.
  4. Peck E, Jelsing E, Onishi K. Advanced ultrasound-guided interventions for tendinopathy. Phys Med Rehabil Clin N Am. 2016; 27(3):733-748.
  5. Sanchez PJ, Grady JF, Saxena A. Percutaneous ultrasonic tenotomy for Achilles tendinopathy is a surgical procedure with similar complications. J Foot Ankle Surg. 2017; 56(5):982-984.
  6. Seng C, Mohan PC, Koh SB, et al. Ultrasonic percutaneous tenotomy for recalcitrant lateral elbow tendinopathy: sustainability and sonographic progression at 3 years. Am J Sports Med. 2016; 44(2):504-510.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Finnoff JT, Hall MM, Adams E, et al. American Medical Society for Sports Medicine position statement: interventional musculoskeletal ultrasound in sports medicine. Clin J Sport Med. 2015; 25(1):6-22.
  2. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification Database. Tenex Health TX System Device Summary. No. K153299. Rockville, MD: FDA. March 2016. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K153299. Accessed on February 15, 2018.
Websites for Additional Information
  1. American Academy of Orthopaedic Surgeons (AAOS). OrthoInfo. Plantar fasciitis and bone spurs. June 2010. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=A00149. Accessed on February 15, 2018.
  2. American Academy of Orthopaedic Surgeons (AAOS). OrthoInfo. Tennis elbow (Lateral epicondylitis). July 2015. Available at: https://orthoinfo.aaos.org/en/diseases--conditions/tennis-elbow-lateral-epicondylitis/.  Accessed on February 15, 2018.
  3. National Library of Medicine (NLM). Medline Plus: Foot injuries and disorders. Available at: http://www.nlm.nih.gov/medlineplus/footinjuriesanddisorders.html. Accessed on February 15, 2018.
Index

Tenex Health TX System
TX1 Tissue Removal System

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.

Document History

Status

Date

Action

Reviewed

05/03/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale, References, and Websites for Additional Information.

New

05/04/2017

MPTAC review. Initial document development.