Frequently Asked Questions Responses by David Toub, MD, MBA, FACOG Medical Director, Gynesonics, Inc.

QUESTION RESPONSE The Sonata® system is intended for diagnostic intrauterine imaging and For what is Sonata transcervical treatment of symptomatic uterine fibroids, including those indicated? associated with .

Safety and effectiveness with regard to fertility and fecundity after use of the Sonata System have not been established. have been reported post-treatment with the Sonata System, and peer-reviewed case reports have Can women desiring fertility been published. Desire for is not a contraindication to the use of be treated with Sonata? Sonata. If you would like to receive this information, please complete the Medical and Scientific Information Request form at https://gynesonics.com/us/request-for-medical-information/.

Can Sonata be used to treat Effectiveness in women with clinically significant has not been adenomyosis? established. At this time, the use of Sonata to treat adenomyosis is off-label.

Sonata can place ablations in a wide range of nonpedunculated fibroid types Which fibroid types are best (submucous, intramural, transmural and subserous). These correspond to suited for treatment with FIGO types 1, 2, 3, 4, 5, 6, and 2-5 (transmural). Sonata?

How much of a fibroid needs While there is literature to suggest that ablation of >20% of a fibroid’s volume to be treated in order for is sufficient for symptom relief through two years, it is apparent that larger ablation to be effective? percentages are preferable and associated with long term efficacy.1 The Instructions for Use for the Sonata System does not specify an upper limit. Clinical trials have involved fibroids generally ≤ 5 cm in maximum diameter. It is important to think in terms of volume. As an example, a 7-cm fibroid has a volume (if approximated as a sphere) of approximately 180 cc and an ablation How large a fibroid can be volume around 90 cc would ablate 50% of the fibroid volume while 145 cc treated with Sonata? would ablate 80%. The largest ablation that the Sonata Treatment Device can make is approximately 42 cc, so 2-3 large ablations would be necessary to ablate 50 % of a 7-cm fibroid while 3-4 would ablate around 80%. There is no set limit to procedure time.

In the SONATA Trial, up to 10 fibroids were treated in enrolled patients. The Instructions for Use for the Sonata System does not specify an upper limit to How many fibroids can be the number of fibroids treated in a single session. How many fibroids to treat treated? will depend on physician judgment.

For first use, it is optimal to consider patients who have 1-2 fibroids ≤6 cm in diameter and preferably with at least one FIGO type 1 or type 2 myoma What is a reasonable first (submucous, nonpedunculated) or type 3 fibroids (abutting the endometrial patient case? layer) associated with heavy menstrual bleeding.

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QUESTION RESPONSE CMS has assigned a CPT code as well as a facility payment rate at the highest level of payment for outpatient Gynecologic procedures (level 6). The facility payment is favorable when compared with the more complex outpatient GYN What is the reimbursement surgical procedures. for the Sonata Procedure? While in category III, gynecologic surgeons will submit for professional fees under the the assigned CPT code (0404T).

How am I going to be trained A Gynesonics trainer will provide didactic and hands-on simulation training and supported? prior to you performing a treatment. In addition, a Gynesonics clinical applications specialist will support you in your initial cases.

The procedural time is determined by the number and size of fibroids being treated. Each ablation ranges from 2-7 minutes, depending on the size of the How long does the Sonata ablation that a gynecologist graphically selects to optimize the volume of the procedure take? fibroid to be ablated. In the SONATA Trial mean time was 47 minutes with a mean of 3 fibroids treated.

A complete summary of anticipated adverse events and potential risks may be found in the Indication and Safety Information handout. Treatment with How should I counsel my Sonata may be associated with spotting and/or leukorrhea. Submucous and patients prior to a procedure transmural fibroids can, undergo sloughing for weeks-months, and even some with Sonata? intramural fibroids will get gradually extruded into the cavity where they may also undergo sloughing.

It is important that patients understand that this is not an instant fix for fibroid symptoms, myomectomy or hysterectomy. How long will my patients as may be expected with While some patients see relief within their first cycle, others take 2-3 cycles still have fibroid symptoms? or longer.

The choice of anesthesia is a clinical decision that is based on multiple considerations, such as BMI, anesthesiologist input and patient and clinician What type of anesthesia is preferences. Sonata clinical trials were conducted with a variety of anesthesia needed? regimens including general or regional and conscious sedation.

In the SONATA clinical trial, 97.9% of patients indicated that the procedure was either “very”, “moderately” or “minimally” tolerable. Patients may experience some pain resulting from the procedure, but clinical data shows Is Sonata a tolerable that the pain is well managed with oral medication (generally NSAIDs) post procedure? procedure. The procedure is not associated with prolonged or intense pain as may be experienced following an embolization procedure or during a global endometrial ablation procedure.

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QUESTION RESPONSE Staging of ablations within 1-3 weeks of initial treatment has not been reported in clinical trials nor in general commercial usage. Patients are Are multiple treatment typically treated in one session. Only a small amount of fluid is used for sessions required? acoustic coupling; fluid overload is not an issue driving the need to interrupt a treatment.

Can cervical dilatation be There is no set routine, but in this country, it is not unusual to consider preop accomplished with misoprostol (Cytotec®) or laminaria tents to help minimize the need for pharmaceuticals or mechanical dilatation. laminaria? It is best for a woman, prior to an expected short procedure, to avoid catheterization and just void on her own en route to the procedure room. There is no disadvantage to having some fluid in the bladder at the time of Is catheterization necessary? TFA, but a full bladder should be avoided since it could be uncomfortable for the patient.

This depends on physician practice or guidelines applicable to a patient. Use Should prophylactic of prophylactic was left up to the physicians in the SONATA clinical antibiotics be given? trial, and 0.7% of patients were administered prophylaxis.

Other than duplicating the time involved, there is no additional benefit but there is no known harm, either. Data has demonstrated that duplicate What happens if two ablation in the same location does not result in a larger ablation. One can, ablations are made in the however, perform multiple adjacent ablations in a single fibroid when desired, same place? and other than the region of overlap, this will lead to a larger treated fibroid volume and is generally desirable.

The time to reach temperature (ramp up) is approximately 1-4 minutes, How long does an ablation depending on ablation size. The ablation times at target temperature is take? 1.5-7 minutes.

Clinicians can always contact the Gynesonics Medical Director: Who can I contact if I have

clinical questions about David Toub, MD, MBA, FACOG transcervical fibroid ablation 215.882.3420 (cell) or patient selection with the [email protected] Sonata system?

1. Stewart EA, Gostout B, Rabinovici J et al. Sustained relief of leiomyoma symptoms by using focused ultrasound surgery. Obstet Gynecol. 2007;279-287.

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