Medical Policy

This document addresses laparoscopic and percutaneous ablative techniques for the treatment of symptomatic uterine fibroids, including radiofrequency ablation using a transcervical approach. Uterine fibroids, also referred to as leiomyomas, is a common condition that affects women in their reproductive years. Symptoms include excessive menstrual bleeding and pelvic pain.

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

• MED.00057 MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Medically Necessary

The use of laparoscopic or transcervical radiofrequency ablation as a treatment for symptomatic uterine fibroids (e.g. excessive uterine bleeding or pelvic discomfort caused by uterine fibroids) is considered medically necessary when all of the following criteria are met:

1. Uterine preservation is desired; and
2. Fibroids are less than 10 cm in any diameter; and
3. Uterine size does not exceed 16 weeks’ gestation.

Not Medically Necessary:

The use of laparoscopic or transcervical radiofrequency ablation as a treatment for uterine fibroids is considered not medically necessary for individuals who do not meet the above criteria.

Investigational and Not Medically Necessary:

The use of all other laparoscopic or percutaneous ablation techniques in combination with imaging guidance as a treatment of uterine fibroids is considered investigational and not medically necessary, including but not limited to lasers, bipolar electrodes, interstitial thermotherapy and cryotherapy.

This document describes clinical studies and expert recommendations, and explains when uterine fibroid ablation using laparoscopic, percutaneous, or transcervical image guided techniques is clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Uterine fibroids are growths in the uterus. They are usually not cancer. Some uterine fibroids do not cause symptoms. Others can cause heavy menstrual periods, pelvic pain, or pelvic pressure. Treatments that can destroy fibroid tissue use heat, cold, or other methods. These include laparoscopic (minimally invasive) procedures such as radiofrequency ablation (Acessa^®), transcervical radiofrequency ablation (Sonata^®), microwave ablation, laser myolysis, and cryomyolysis. Each option has possible benefits and harms. Some options have not been studied enough to know if they improve health.

• Laparoscopic radiofrequency ablation (Acessa) uses heat to treat fibroids through small cuts in the belly.
• Transcervical radiofrequency ablation (Sonata) uses heat to treat fibroids through the cervix.
• Microwave ablation uses heat from microwave energy.
• Laser myolysis uses laser energy to destroy fibroid tissue.
• Cryomyolysis uses very cold temperatures to destroy fibroid tissue.

What is Clinically Appropriate?

Laparoscopic radiofrequency ablation (Acessa) or transcervical radiofrequency ablation (Sonata) may be clinically appropriate in these circumstances:

• The person wants to keep the uterus; and
• Fibroids are less than 10 cm across in any direction; and
• The uterus is not larger than the size of a uterus at 16 weeks of pregnancy.

What is Not Clinically Appropriate?

Laparoscopic radiofrequency ablation (Acessa) or transcervical radiofrequency ablation (Sonata) is not clinically appropriate when the criteria above are not met.

Other laparoscopic or minimally invasive techniques that use imaging guidance are also not clinically appropriate. These include microwave ablation, laser myolysis, bipolar electrodes, interstitial thermotherapy, and cryomyolysis. The available studies for these procedures have been small, lacked comparison groups, had limited follow-up, or showed mixed results. Better comparative studies with longer follow-up are needed to determine whether these treatments provide lasting health benefits compared with established treatment options.

(Return to Description/Scope)

Summary

Laparoscopic radiofrequency volumetric thermal ablation (RFVTA) and transcervical radiofrequency ablation are minimally invasive treatments for symptomatic uterine fibroids. The Acessa and Sonata systems received U.S. Food and Drug Administration (FDA) clearance through the 510(k) process.

Evidence from one small randomized trial, prospective studies, and systematic reviews indicates that laparoscopic RFVTA can reduce fibroid-related symptoms and improve quality of life with less operative blood loss and faster hospital discharge than laparoscopic myomectomy.

Evidence for transcervical radiofrequency ablation consists primarily of prospective uncontrolled studies reporting reduced bleeding, improved symptoms and quality of life, and low reintervention rates in pivotal trials. A recent randomized trial found faster short-term recovery after transcervical ablation than after minimally invasive myomectomy, but did not evaluate long-term symptom control, recurrence, reintervention, fertility, or pregnancy outcomes.

The medical necessity criteria reflect the populations in whom these procedures have been studied.

• The requirement that uterine preservation be desired recognizes that radiofrequency ablation is a uterine-sparing alternative to hysterectomy and myomectomy, but should not be interpreted as evidence that fertility is preserved. Reproductive outcome data remain limited, and many studies excluded individuals planning pregnancy.
• The requirement that fibroids measure less than 10 cm is based primarily on the inclusion criteria of the laparoscopic randomized trial and postmarket studies. Most transcervical studies treated substantially smaller fibroids, and evidence for treating fibroids approaching 10 cm is limited.
• The requirement that uterine size not exceed 16 weeks’ gestation likewise reflects the upper boundary of the studied laparoscopic population; evidence is insufficient to determine the safety and effectiveness of radiofrequency ablation in substantially larger uteri. These size thresholds therefore represent evidence-based limits of the available study populations rather than validated cutoffs demonstrating equivalent outcomes across all fibroid sizes or treatment approaches.

The American College of Obstetricians and Gynecologists (ACOG) states that laparoscopic radiofrequency ablation may be considered for symptomatic leiomyomas in individuals who desire uterine preservation and are counseled regarding limited reproductive outcome data. No authoritative guidance or high-quality comparative evidence supports expanding treatment beyond the currently studied fibroid and uterine size limits.

Evidence for microwave ablation, Nd:YAG laser myolysis, cryomyolysis, bipolar ablation, and interstitial thermotherapy remains insufficient because available studies are small, uncontrolled, heterogeneous, or lack long-term comparative outcomes.

Discussion

Laparoscopic radiofrequency volumetric thermal ablation

In 2012, the FDA cleared the Acessa System (Originally Halt Medical, Inc., now Hologic, Inc.) through the 510(k) process for use in percutaneous coagulation and ablation of soft tissue under laparoscopic ultrasound guidance, including treatment of symptomatic uterine fibroids. No controlled data were presented in the 510(k) summary.

One randomized controlled trial (RCT) has evaluated RFVTA for the treatment of uterine fibroids. The blinded study by Brucker and colleagues (2014) compared RFVTA and laparoscopic myomectomy in 51 women with symptomatic fibroids and reported on length of hospitalization and perioperative outcomes. Study participants were at least 18 years old with symptomatic uterine fibroids, had a uterine size ≤ 16 gestational weeks as determined by pelvic exam and had fibroids that were less than 10 cm in any diameter. Individuals in the treatment group experienced significantly faster discharge from the hospital and less mean operative blood loss. In 2016, Kramer and colleagues published 2-year results of this study. At 2 years, there were no significant differences between the RFVTA and myomectomy groups in the frequency of symptoms including heavy menstrual bleeding, pelvic pain and frequency of urination. Three individuals in the RFVTA group sought additional surgical interventions; the authors noted this was not due to fibroid symptoms. No one in the myomectomy group had surgical re-intervention. Three individuals in the RFVTA group and 6 in the myomectomy group conceived and there were no miscarriages. Limitations include manufacturer sponsorship of the trial, homogenous sample population (lack of ethnic diversity), and interim reporting of study results (2-year findings out of 5 years total that participants were to be followed).

In addition to the RCT, there are several case series. Some had sample sizes of fewer than 50 participants (Garza 2011; Robles 2013). One of the larger case series evaluating RFVTA, reported by Galen and colleagues (2014), was retrospective and included 206 individuals. From baseline to 12 months, participants experienced significant reductions in symptom severity (p<0.001); health-related quality of life (HR-QOL) scores (p<0.001); and mean uterine volume (p=0.008). The rate of adverse events associated with the RFVTA procedure was relatively low at 1.4% (1 of 69).

Chudnoff and colleagues (2013) reported on a case series involving 135 subjects with symptomatic uterine myomas who underwent laparoscopic ultrasound-guided RFVTA. Subjects were premenopausal women with uterine size of 14 weeks gestation or less and six or fewer treatable myomas. No myoma was larger than 7 cm in diameter and total myoma volume was 300 cm³ or less. At 12 months, 127 subjects were included in the analysis. The authors reported that, compared with baseline, monthly menstrual blood loss, myoma volume and total uterine volume were significantly lower at 12 months. Results on the Uterine Fibroid Symptom and Quality of Life Questionnaire (UFSQOL) indicated significant improvements in both symptom severity and HR-QOL (p<0.001 for both measures). Similar results were also reported for the responses on the EQ-5D^™ Health Status score (p<0.001).

Guido and colleagues (2013) conducted a case series to evaluate RFVTA of symptomatic uterine fibroids in 121 premenopausal women (HALT Trial). At the 24-month follow-up, subjects showed significant improvement in symptom severity compared with baseline values (p<0.001), as well as significant improvements in HR-QOL scores in all categories (p<0.001). A total of 6 individuals (4.8%) required repeat surgical intervention for bleeding related to fibroids between 12 and 24 months. At 36 months of follow-up, Berman (2014) reported similar results in 104 subjects from the same trial. RFVTA resulted in continued and significant relief from symptoms of uterine fibroids, including significant improvements in HR-QOL scores. At 36 months, the total rate of re-intervention was 11% (14 of 135 subjects).

Data from the published studies have been summarized in systematic reviews (Bradley, 2019; Lin, 2019). Both the Bradley and Lin systematic reviews presented data on RFVTA only. Bradley (2019), which focused on laparoscopic radiofrequency ablation, included eight studies in their review, among them the Kramer RCT, discussed above, as well as seven uncontrolled studies. In an analysis pooling study findings on RFVTA, the mean change from baseline to 12 months in HR-QOL was 42 points (95% confidence interval [CI], 39 to 44 points; p<0.001), and in the symptom score was -39 points (95% CI, 35 to 44; p<0.001). The overall rate of reintervention in seven studies was 4.39%. (95% CI, 1.60 to 8.45%).

A post-market study of safety data was published by Yu and colleagues in 2020. The authors reported on 48-hour and 30-day outcomes in individuals undergoing RFVTA conducted by 29 surgeons who were trained in performing the procedure during the study run-in period. A total of 110 individuals were enrolled, of which 101 and 104, respectively, completed the 48-hour and 30-day post-procedure visits. The individuals in the study were enrolled in an ongoing RCT and met the criteria of being at least 18 years old, menstruating, with symptomatic uterine fibroids no larger than 10 cm in the greatest diameter and who desired uterine-sparing treatment. There were no serious adverse events reported within 48 hours, and one serious adverse event (1/105, 0.95%) was reported within 30 days. This was a hospitalization for post-operative fever and tachycardia, and the adverse event was determined by an independent review committee to be “probably device-related.” Longer term adverse events were not reported in this analysis.

The ACOG guideline on Management of Symptomatic Uterine Leiomyomas (June 2021, reaffirmed 2025) included the following “Level B” recommendation (recommendation based on limited or inconsistent scientific evidence), “Laparoscopic radiofrequency ablation can be considered as a minimally invasive treatment option for the management of symptomatic leiomyomas in patients who desire uterine preservation and are counseled about the limited available data on reproductive outcomes”. The bulletin noted that “laparoscopic RFA with a leiomyoma specific FDA-approved device has been studied primarily in nonrandomized trials” and the recommendation was based in part on recent meta-analyses, Bradley (2019) and Lin (2019), discussed above. The guideline provides three “Level A” recommendations (recommendations based on good and consistent scientific evidence):

• Gonadotropin-releasing hormone (GnRH) agonists, either with or without add-back hormonal therapy, are recommended for the short-term treatment of AUB-L [Abnormal Uterine Bleeding associated with Leiomyomas] and uterine enlargement associated with uterine leiomyomas and as a bridge to other treatment strategies.
• Uterine artery embolization (UAE) is recommended as an interventional procedure for the treatment of uterine leiomyomas in patients who desire uterine preservation and are counseled about the limited available data on reproductive outcomes.
• When hysterectomy is selected for the surgical management of symptomatic uterine leiomyomas, the most minimally invasive route is recommended whenever possible, and the vaginal approach is preferred among the minimally invasive approaches when it is feasible.

Transcervical radiofrequency ablation

In 2018, the FDA cleared the Sonata Sonography-Guided Transcervical Fibroid Ablation System (Gynesonics, Inc., now Hologic, Inc.) through the 510(k) process for treatment of symptomatic uterine fibroids. Data from single-arm trials, but no controlled data, were presented in the 510(k) summary.

Transcervical ablation was evaluated in an uncontrolled prospective multicenter study known as the SONATA trial (Chudnoff, 2019). The study included 147 premenopausal individuals between the ages of 25 and 50 years who had 1 to 10 uterine fibroids, at least 1 of which indented or impeded on the endometrial cavity. Moreover, participants were required to have a minimum pictorial blood loss assessment chart score between 150 and 500. The chart is a validated instrument that asks individuals to estimate blood loss by choosing among icons representing various types of sanitary products. Exclusion criteria included a desire for future pregnancy, uterine volume 1000 cm³ or greater, a type 0 myomata that was 1.0 cm or greater, endometrial polyps 1.5 cm or greater or multiple polyps. Co-primary endpoints, assessed at 12 months after ablation, were reduction in menstrual blood loss (assessed by a pictorial blood loss assessment chart) and the rate of surgical reintervention for heavy menstrual bleeding. At 12 months, the mean pictorial blood loss assessment chart score was 51% lower than baseline and 99.3% of individuals did not undergo surgical reintervention.

Findings up to 3 years have been reported. Two-year findings of the SONATA trial were published by Miller and Osman in 2019. Data were available on 125 of 147 (85%) study participants. During the 2-year follow-up period, 5.5% of individuals had undergone reintervention for heavy menstrual bleeding. The article did not report 2-year results on the other co-primary outcome, change in blood loss. Among secondary outcomes, the symptom severity score (SSS) decreased from a mean of 55 (Standard Deviation [SD], 19) to 24 (SD, 18) at 2 years, p<0.001. Moreover, health-related quality of life scores increased from a mean of 40 (SD, 21) to 83 (SD, 19), p<0.001. Lukes and Green (2020) reported 3-year results of the SONATA trial, at which time the investigators accounted for 132 (90%) of participants. The rate of surgical reintervention was 9.2% at 3 years using the binomial method and 8.2% using the Kaplan-Meier method. At 3 years, the mean SSS was 22 (SD, 21) and the mean HR-QOL score was 83 (SD, 23).

An uncontrolled prospective multicenter study, the FAST-EU trial, evaluated treatment with the VizAblate System, an earlier version of Sonata (Bongers, 2015; Brölmann, 2016). The study included 50 non-pregnant individuals age 28 and older with regular menstrual cycles and abnormal uterine bleeding for at least 3 months. Eligible individuals had 1 to 5 uterine fibroids between 1 and 5 cm in maximum diameter. A desire for future fertility was an exclusion criterion. The primary endpoint was the percentage change in fibroid perfused volume from baseline to 3 months, as assessed by contrast-enhanced magnetic resonance imaging (MRI). Mean total fibroid volume decreased from 18.8 cm³ (SD, 21.4) at baseline to 8.0 cm³ (SD, 1.9) at 3 months, a mean percent reduction of 54.7%, p<0.001. At 12 months, the mean percent reduction of total fibroid volume was 66.1%. In addition, mean perfused fibroid volume decreased from 18.3 cm³ (SD, 20.6) at baseline to 5.8 cm³ (SD, 9.6) at 3 months and 6.6 cm³ (SD, 11.3) at 12 months. Mean percent reduction of perfused fibroid volume was 68.1% at 3 months and 67.4% at 12 months.

Shifrin (2022) conducted a pooled analysis of data on submucous fibroids and fibroids > 5.0 cm in diameter from the SONATA and FAST-EU trials. In these two studies, there were a total of 72 women with at least one submucous fibroid and 19 women with at least one fibroid > 5.0 cm; the largest fibroid was 6.5 cm in diameter. For women with submucous fibroids, the mean SSS at 12 months improved by 39 points in the FAST-EU trial and by 31 points in the SONATA trial. For women with fibroids > 5.0 cm, the mean SSS at 12 months improved by 35 points in the FAST-EU trial and by 41 points in the SONATA trial. The rates of surgical reintervention through 1 year in women with submucous fibroids was 3.7% in the FAST-EU trial and 0% in the SONATA trial.

In 2021, Arnreiter and colleagues published a systematic review of studies evaluating the Sonata device. The authors identified 10 eligible studies, of which 7 were single-arm studies and 3 were case reports. No controlled studies were identified. In the 4 studies that reported these outcomes, the mean decrease in fibroid volume 3 months after treatment was 68.1% in perfused volume and 54.7% in absolute myoma volume. At 12 months, there was a mean reduction of 63.2% in myoma volume and 64.5% in perfused volume. Moreover, the mean SSS was 56.7 at baseline and 23.7 at the 12 months. The average HR-QOL score was 38.8 at baseline and 83.3 at 12 months.

A retrospective review of data on 53 individuals who underwent Sonata treatment at a single center was published by van der Meulen and colleagues in 2022. The median number of ablated fibroids was 1, with a range of 1 to 5. The median fibroid maximum diameter at baseline was 41 mm. Median length of follow-up post-surgery was 36 months, with a range of 13 to 101 months. During follow-up, 24 of 53 women (45%) underwent surgical reintervention. The median time to first surgical reintervention was 11 months and the most common reintervention was a hysteroscopic myomectomy. A total of 49 of the 53 women gave consent to participate in a survey and all of these responded to the survey. A total of 35 of the 49 respondents (71%) indicated that their fibroid-related symptoms had improved post-surgery. Among the remaining women, 13 stated their symptoms were unchanged and 1 indicated that symptoms had deteriorated. Fibroid size was evaluated in 39 women by transvaginal ultrasound at a mean time of 4.3 months post-procedure. The substantially higher reintervention rate in this real-world cohort compared with the pivotal SONATA trial highlights uncertainty regarding the long-term durability and generalizability of transcervical radiofrequency ablation outcomes.

Hansen-Lindner and colleagues (2024) evaluated data from manufacturer-sponsored trials of Sonata treatment and post-marketing data collected through March 2024. They identified 89 pregnancies reported to physicians that occurred in 72 women after Sonata treatment. Pregnancy outcomes were available for 62 women. There were 55 deliveries (19 vaginal deliveries and 35 Cesarean sections), 5 therapeutic abortions, 18 first-trimester spontaneous abortions, 1 ectopic pregnancy and 1 delivery by an unknown route. The 18 first-trimester spontaneous abortions occurred in 10 women; 10 of 18 of these miscarriages occurred in 2 women with a history of multiple miscarriages. The mean birthweight was 3267 grams (median, 3355 grams). There were no reported cases of uterine rupture, placenta accreta spectrum or stillbirth.

In 2026, Neis and colleagues published the planned 7-week recovery analysis from an RCT comparing outcomes with transcervical fibroid ablation (TFA) using the Sonata system with minimally invasive myomectomy (MIM) in women with symptomatic uterine fibroids. A total of 144 premenopausal women aged 18-50 years with symptomatic uterine fibroids were randomized to undergo TFA or MIM (n=72, both groups); however, follow-up data for the primary endpoint were available for 119 participants (58 TFA and 61 MIM). The primary endpoint, time to return to normal activities, favored TFA (5.5 vs. 13 days; log-rank p<0.001). Procedure time, postoperative pain, opioid use, discharge readiness, and 9 of 10 treatment recovery metrics (including household tasks, lifting/carrying items, driving, recreational tasks, return to work, urination, regular diet, normal sleep, and sexual intercourse) also favored TFA, while normal bowel function did not differ between groups. One serious adverse event was reported in the MIM group, and none occurred in the TFA group. The authors concluded that TFA provided faster short-term recovery than MIM. However, interpretation of these findings is limited by the single-center design, industry funding, incomplete follow-up, unequal rates of concomitant procedures between groups, and the absence of long-term comparative data regarding symptom control, reintervention, fertility outcomes, or recurrence.

Overall, available evidence indicates that transcervical radiofrequency ablation can improve bleeding, fibroid-related symptoms, and quality of life and may provide faster short-term recovery than minimally invasive myomectomy. However, much of the evidence is derived from uncontrolled studies, reported reintervention rates vary between pivotal and real-world studies, and long-term comparative, fertility, and pregnancy outcomes remain uncertain.

Microwave ablation

In 2018, Ierardi and colleagues published a systematic review of the published literature on percutaneous high-frequency microwave ablation for the treatment of uterine fibroids. The authors identified six studies with a total of 541 participants. All of the studies were case series; there were no RCTs or non-randomized controlled studies. The rate of clinical success, defined as reduction in uterine fibroid volume, in the individual studies ranged from 15.9% to 93.1%. The authors stated that this wide range in findings was due, at least in part, to different lengths of follow-up in the studies. No major complications were reported in any of the studies and the minor complications were primarily those that would be expected after this type of intervention. The authors did not pool study findings.

The largest series was published by Liu and colleagues in 2017. The study prospectively enrolled 311 Chinese women who underwent ultrasound-guided percutaneous microwave ablation therapy for symptomatic uterine fibroids. Women were evaluated at baseline, 3, 6 and 12 months for fibroid size, hemoglobin level, uterine fibroid symptoms and HR-QOL scores. The mean reduction rate in fibroid volume was 63.5%, 78.5% and 86.7% at 3, 6 and 12 months, respectively (p<0.001). The mean hemoglobin level increased significantly from 88.84 ± 9.31 g/L at baseline to 107.14 ± 13.32, 116.05 ± 7.66 and 117.79 ± 6.51 g/L at 3, 6 and 12 months posttreatment, respectively (p<0.001). The symptom severity score (SSS) and HR-QOL scores were also significantly improved at each follow-up compared with baseline (p<0.001). While these results are promising, a randomized trial comparing microwave ablation of uterine fibroids to standard of care in a diverse population with long-term outcomes is warranted.

A case series published by Yang and colleagues in 2019 enrolled 69 participants. Data were available for 48 participants (70%) at 3 months. Compared with baseline, the symptom severity score decreased from 34.5 to 12.7 (p<0.001) and the mean myoma volume decreased from 221.7 cm³ to 87.2 cm³. Loss to follow-up was close to 50% at 6 and 12 months. As with previous case series, this study lacks a comparison group and it was also limited by the high drop-out rate.

Nd:YAG laser myolysis

Hindley (2002) and colleagues reported on a case series of 66 women with symptomatic fibroids who were treated with MRI-guided percutaneous Nd:YAG laser myolysis. Outcome measures included assessment of fibroid size and a menorrhagia questionnaire. The mean reduction in size of fibroids was 31%. Compared to a control group of those undergoing hysterectomy, the total outcome score was less in those undergoing percutaneous myolysis but the quality of life score was similar. Although not entirely clear, it appears that treatment was targeted to only the largest fibroid in each woman. The study does not provide details on the number and location of fibroids. It should also be noted that MRI guidance was provided with a high field (0.5T) open machine.

Cryomyolysis

Zreik and colleagues (2008) reported findings in 14 women who underwent cryomyolysis, while Zupi and colleagues (2004; 2005) presented initial experience with 20 women. In both of these small case series, the authors reported post-intervention symptom resolution. In the Zreik study, the participants were given GnRH agonist before the procedure; cryomyolysis maintained or slightly reduced the post-GnRH uterine size. In contrast, GnRH was not used in the Zupi study, and cryomyolysis was associated with a 25% reduction in fibroid size, and a resolution of bleeding at 12 months.

Other Considerations

In 2008, the American Society of Reproductive Medicine (ASRM) in collaboration with the Society of Reproductive Surgeons (SRS) published a joint statement regarding myomas and reproductive function. In this document they stated:

Another laparoscopic technique, myolysis, involves thermal destruction of myomas via insertion of cryoprobes, electrocautery needles, or fiberoptic lasers. A nonsurgical method for myolysis involving MRI-guided focused ultrasound has also been described. Data relating to the short- and long-term outcomes achieved with such treatments are still lacking and, until they become available, myolysis cannot be recommended for women hoping to maintain or improve their fertility.

Uterine fibroids is one of the most common conditions affecting women during their reproductive years. Symptoms include menorrhagia, pelvic pressure, or pain. Hysterectomy and various myomectomy procedures are considered the gold standard of treatment. However, there has been continual research interest in developing minimally invasive alternatives that may preserve fertility, including endometrial ablation (for submucosal fibroids), uterine artery embolization, and various techniques to induce myolysis.

Several types of energy sources have been used for myolysis, including Nd:YAG lasers, bipolar electrodes, cryotherapy, or radiofrequency ablation. Radiofrequency ablation can be applied using the laparoscopic or transcervical approach. In general, the procedures involve the insertion of probes multiple times into the fibroid. When activated, the various energy sources induce devascularization and ultimately ablation of the target tissue.

Myolysis, a surgical procedure that involves the destruction of uterine fibroids (also referred to as leiomyomas), has typically been performed during a laparoscopic procedure focusing on subserosal and intramural fibroids; more recently, percutaneous approaches with magnetic resonance imaging (MRI) guidance have been reported. Typically, women are pretreated with depot gonadotropin-releasing hormone (GnRH) agonists, over a period of 2 to 6 months, to shrink fibroids prior to the procedure.

Cryomyolysis is a technique in which a cryoprobe is inserted into the center of a fibroid. Freezing temperatures of minus 180 degrees centigrade create an “iceball” within the fibroid. Several freeze/thaw cycles are typically used.

Incidence rates of fibroids are typically found to be two to three times higher in black women than in white women, with symptoms developing on average 4 to 6 years sooner in black women compared with white women (Marsh, 2013; Templeman, 2009; Yu, 2018). Moreover, rates of hysterectomy and myomectomy for fibroids are higher in black women than white women, and among women undergoing hysterectomy or myomectomy, black women tend to have surgery at a younger age and have larger uteri, more severe anemia, and experience increased rates of hospitalization (Alexander, 2019; Wechter, 2011). While healthcare disparities continue to present a complex challenge, minimally invasive ablative techniques for the treatment of uterine fibroids lack robust supporting data, including evaluation of long-term health outcomes, and have not been shown improve net healthcare outcomes relative to the gold standard of treatment (hysterectomy and various myomectomy procedures), irrespective of race, geographic residence, and access to health care.

Uterine size, measured via pelvic exam, is a common method of reporting uterine size. As in the Brucker (2014) study, uterine size (as part of candidacy assessment for radiofrequency ablation of uterine fibroids) can be estimated using weeks’ gestation. The uterine size is described in terms of the fundal height in the superior-inferior axis in comparison to a gravid uterus:12 weeks is palpable just above the pubic symphysis, 16 weeks is midway between the symphysis and umbilicus, and 20 weeks is at the umbilicus. Uterine size as determined by gestational age can be converted to an approximate length in cm in the absence of an ultrasound measurement. A uterus that is 16-weeks’ gestational size correlates to 16 cm.

Cryomyolysis: A procedure that destroys uterine fibroid tissue by applying extremely cold temperatures through a cryoprobe.

Fibroids: Benign tumors composed primarily of smooth muscle and connective tissue that develop in or around the uterus; also called leiomyomas or myomas.

Interstitial thermotherapy: A procedure in which heat is delivered through a probe placed within tissue to destroy the targeted tissue.

Laparoscopic: Performed through small abdominal incisions using a thin camera and specialized surgical instruments.

Laparoscopic radiofrequency ablation: Radiofrequency ablation of uterine fibroids performed through small abdominal incisions with laparoscopic ultrasound guidance.

Magnetic resonance imaging (MRI): A noninvasive imaging method that uses a magnetic field and radio waves to produce detailed images of internal tissues and organs.

Microwave ablation: A procedure that uses microwave energy to heat and destroy targeted fibroid tissue.

Myolysis: A procedure that destroys uterine fibroid tissue using heat, cold, laser energy, electrical energy, or another energy source.

Myomectomy: Surgical removal of one or more uterine fibroids while leaving the uterus in place.

Percutaneous: Performed through a needle or small instrument inserted through the skin.

Radiofrequency ablation (RFA): A procedure that uses radiofrequency energy to heat and destroy targeted tissue.

Reintervention: An additional procedure or surgery performed because of persistent or recurrent fibroid-related symptoms after the initial treatment.

Symptomatic uterine fibroids: Uterine fibroids associated with clinically meaningful symptoms such as excessive menstrual bleeding, pelvic pain or pressure, urinary symptoms caused by compression, or other bulk-related symptoms.

Transcervical: Performed through the cervix without an abdominal incision.

Transcervical radiofrequency ablation: Radiofrequency ablation of uterine fibroids performed through the cervix using intrauterine ultrasound guidance.

Uterine preservation: Retention of the uterus after treatment. Uterine preservation does not necessarily mean that fertility or future pregnancy outcomes are preserved.

Uterine size by gestational age: A clinical estimate of uterine enlargement based on comparison with the expected size of the uterus during pregnancy. This estimate does not necessarily correspond to a single uterine measurement on imaging.

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 may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure and diagnosis codes listed above when criteria are not met and for all other diagnoses not listed.

When services are Investigational and Not Medically Necessary:

Peer Reviewed Publications:

1. Alexander AL, Strohl AE, Rieder S, et al. Examining disparities in route of surgery and postoperative complications in black race and hysterectomy. Obstet Gynecol. 2019; 133(1):6-12.
2. Arnreiter C, Oppelt P. A systematic review of the treatment of uterine myomas using transcervical ultrasound-guided radiofrequency ablation with the Sonata^® System. J Minim Invasive Gynecol. 2021; 28(8):1462-1469.
3. Berman JM, Guido RS, Garza Leal JG, et al. Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas. J Minim Invasive Gynecol. 2014; 21(5):767-774.
4. Bongers M, Brölmann H, Gupta J, et al. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate^® System: three- and six-month endpoint results from the FAST-EU study. Gynecol Surg. 2015; 12(1):61-70.
5. Bradley LD, Pasic RP, Miller LE. Clinical performance of radiofrequency ablation for treatment of uterine fibroids: systematic review and meta-analysis of prospective studies. J Laparoendosc Adv Surg Tech A. 2019; 29(12):1507-1517.
6. Brölmann H, Bongers M, Garza-Leal JG, et al. The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids. Gynecol Surg. 2016; 13:27-35.
7. Brucker SY, Hahn M, Kraemer D, et al. Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy. Int J Gynaecol Obstet. 2014; 125(3):261-265.
8. Chudnoff SG, Berman JM, Levine DJ, et al. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol. 2013; 121(5):1075-1082.
9. Chudnoff S, Guido R, Roy K, et al. Ultrasound-guided transcervical ablation of uterine leiomyomas. Obstet Gynecol. 2019; 133(1):13-22.
10. Galen DI, Pemeuller RR, Leal JG, et al. Laparoscopic radiofrequency fibroid ablation: phase II and phase III results. JSLS. 2014; 18(2):182-190.
11. Garza Leal JG, Hernandez LI, Castillo SL, Lee BB. Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System. J Minim Invasive Gynecol. 2011; 18(3):364-371.
12. Guido RS, Macer JA, Abbott K, et al. Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years’ outcome from the Halt trial. Health Qual Outcomes. 2013; 11(1):139.
13. Hansen-Lindner L, Schmid-Lossberg J, Toub D. Transcervical fibroid ablation (TFA): update on pregnancy outcomes. J Clin Med. 2024; 13(10):2892.
14. Hindley JT, Law PA, Hickey M, et al. Clinical outcomes following percutaneous magnetic resonance image guided laser ablation of symptomatic uterine fibroids. Hum Reprod. 2002; (1)7:2737-2741.
15. Ierardi AM, Savasi V, Angileri A, et al. Percutaneous high-frequency microwave ablation of uterine fibroids: systematic review. Biomed Res Int. 2018 Jan 8: 2018:2360107.
16. Krämer B, Hahn M, Taran FA, et al. Interim analysis of a randomized controlled trial comparing laparoscopic radiofrequency volumetric thermal ablation of uterine fibroids with laparoscopic myomectomy. Int J Gynaecol Obstet. 2016; 133(2):206-211.
17. Law P, Gedroyc WM, Regan L. Magnetic resonance-guided percutaneous laser ablation of uterine fibroids. J Magn Reson Imaging. 2000; 12(4):565-570.
18. Lin L, Ma H, Wang J, et al. Quality of life, adverse events, and reintervention outcomes after laparoscopic radiofrequency ablation for symptomatic uterine fibroids: a meta-analysis. J Minim Invasive Gynecol. 2019; 26(3):409-416.
19. Liu H, Zhang J, Han ZY, et al. Effectiveness of ultrasound-guided percutaneous microwave ablation for symptomatic uterine fibroids: a multicentre study in China. Int J Hyperthermia. 2016; 32(8):876-880.
20. Lukes A, Green MA. Three-year results of the SONATA pivotal trial of transcervical fibroid ablation for symptomatic uterine myomata. J Gynecol Surg. 2020; 36(5):228-233.
21. Marsh EE, Ekpo GE, Cardozo ER, et al. Racial differences in fibroid prevalence and ultrasound findings in asymptomatic young women (18-30 years old): a pilot study. Fertil Steril. 2013; 99(7):1951-1957.
22. Miller CE, Osman KM. Transcervical radiofrequency ablation of symptomatic uterine fibroids: 2-year results of the SONATA pivotal trial. J Gynecol Surg. 2019; 35(6):345-349.
23. Neis F, Kraemer B, Bauer A, et al. Recovery after transcervical fibroid ablation versus minimally invasive myomectomy for symptomatic uterine fibroids: a randomised controlled trial. BJOG. 2026; 133(4):618-625.
24. Robles R, Aguirre VA, Argueta AI, Guerrero MR. Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up. Int J Gynaecol Obstet. 2013; 120(1):65-69.
25. Shifrin G, Engelhardt M, Gee P, et al. Transcervical fibroid ablation with the Sonata^™ system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet. 2021; 155(1):79-85.
26. Templeman C, Marshall SF, Clarke CA, et al. Risk factors for surgically removed fibroids in a large cohort of teachers. Fertil Steril. 2009; 92(4):1436-1446.
27. van der Meulen JF, Cooijmans TH, van Zutven VJ, et al. Long-term results of transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the Sonata System: a retrospective follow-up study. AJOG Glob Rep. 2022; 2(4):100087.
28. Wechter ME, Stewart EA, Myers ER, et al. Leiomyoma-related hospitalization and surgery: prevalence and predicted growth based on population trends. Am J Obstet Gynecol. 2011; 205(5):492.e1-492.e4925.
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Government Agency, Medical Society, and Other Authoritative Publications:

1. American College of Obstetricians and Gynecologists (ACOG). Management of Symptomatic Uterine Leiomyomas: ACOG Practice Bulletin, Number 228. Obstet Gynecol. 2021; 137(6):e100-e115.
2. American Society of Reproductive Medicine. Myomas and reproductive function. The Practice Committee of the American Society of Reproductive Medicine in collaboration with the Society of Reproductive Surgeons. Fertil Steril. 2008; 910(5 Suppl):S125-S130.
3. U.S. Food and Drug Administration 510(k) Premarket Notification Database. The Acessa System Summary of Safety and Effectiveness. No. K121858. Rockville, MD. November 5, 2012. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121858.pdf. Accessed on June 25, 2026.
4. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Sonata^® Sonography-Guided Transcervical Fibroid Ablation System Summary of Safety and Effectiveness. No. K173703. Rockville, MD. August 15, 2018. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173703.pdf. Accessed on June 25, 2026.

1.  National Institute of Child Health and Human Development. Uterine fibroids. Last Reviewed November 2, 2018. Available at: https://www.nichd.nih.gov/health/topics/uterine. Accessed on June 25, 2026.
2. National Library of Medicine. Medline Plus Health Topics: Uterine fibroids. Last updated March 24, 2025. Available at: htp://www.nlm.nih.gov/medlineplus/uterinefibroids.html. Accessed on June 25, 2026.

Laparoscopic
Myolysis
Percutaneous
Radiofrequency volumetric thermal ablation (RFVTA)
Transcervical
Uterine Fibroids

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