Sonata Treatment: Patient Selection & Counseling Considerations - Gynesonics

Sonata Treatment:
 Patient Selection & Counseling Considerations
                                             Kelly Roy, MD
                                 Arizona Gynecology Consultants, Phoenix
                  Assistant Program Director, MIGS Fellowship Banner University Medical Center
                       Assistant Clinical Professor, University of Arizona College of Medicine

1 | ML 06072 -001.A

Patient Selection Considerations

 Symptoms
 Fibroid location
    • All non-pedunculated fibroid types
    • Intrauterine ultrasound image               guidance
           optimizes access and treatment of fibroids
           indenting or closest to the cavity with Sonata -
           those correlated to HMB (submucous,
           transmural and intramural)

 4 | ML 06072 -001.A

Patient Selection Considerations (continued)
    Fibroid size
          • Published experience includes fibroids 7-8 cm
          • Fibroids ≥ 6cm require multiple ablations to optimize volume reduction

    Number of fibroids - up to 10 fibroids were ablated/patient during SONATA Trial
    Safety and effectiveness with regard to fertility and fecundity after the use of the
     Sonata System have not been established
    Effectiveness in women with clinically significant adenomyosis has not been
     established

5 | ML 06072 -001.A

Sonata Contraindications

  Current pregnancy
  Active pelvic infection
  Known or suspected gynecologic malignancy or premalignant disorders
   such as atypical endometrial hyperplasia
  Presence of one or more intratubal implants for sterilization; and
  Presence of an intrauterine device (IUD), unless removed prior to the
   introduction of the Sonata Treatment Device.

6 | ML 06072 -001.A

Patient Selection: Considerations for New Users

 Ideal patient selection for new Sonata users:
  Primary target of Type 1, 2 or 3 myoma ≤6 cm in diameter
        • Higher likelihood of success/symptom improvement (fibroid associated with HMB, ability
               to target and treat fibroid with single ablation)
        • Associated with increased safety margin between fibroid and serosa
  Limited number of fibroids to treat, preferably no more than 3 fibroids
  Avoid patients presenting only with isolated subserous fibroids

8 | ML 06072 -001.A

Patient Selection in My Practice

  Patient’s goal – no bleeding vs. reduced bleeding

  Age and proximity to possible menopause

  Symptoms?

  Work up?

  Prior fibroid treatments?

  Fibroid size/number/location

9 | ML 06072 -001.A

Patient Challenges

  LUS fibroid (need ~2.3 cm of space for Ablation Guide)

  Tight cervix/cervical stenosis

  Marked anteflexion/retroflexion

  Intrauterine adhesions

10 | ML 06072 -001.A

Case Example
                •      41 yo G2P2
                •      Chief complaint: heavy menstrual bleeding x 4 years
                •      HPI: Menarche age 13; regular menses (27-28 day cycles, 3-day menses) but heavy with occasional clots (“I go
                       through at least 1-2 pads/hour on the first day”). Had tried OCPs without success. Had a course of tranexamic
                       acid but developed leg pain and this was d/c’d.
                •      PMHx: Negative; denies history of bleeding disorders, endometriosis
                •      PSHx: s/p tubal ligation
                •      Physical exam: RF/RV uterus, mobile, 8 weeks’ size, nontender. Parous os. No adnexal masses.
                •      TV U/S: Enlarged uterus with a 3.0-cm type 1 myoma (submucous,

Case Example: Clinical Course
                             Baseline                     3 Months                      12 Months
                         3-cm type 1 myoma           88% Volume Reduction          100% Volume Reduction
                       Symptom Severity Score = 59   Symptom Severity Score = 28    Symptom Severity Score = 1

13 | ML 06072 -001.A                                             MR series courtesy of Jose Gerardo Garza-Leal, MD

Case Example: Type 4 Myoma
                            Baseline                                   12 Months
                  1.6-cm anterior type 4 myoma                    96% Volume Reduction

14 | ML 06072 -001.A
                                                 MR series courtesy of José Gerardo Garza-Leal, MD

Patient Turned Advocate

    Healthy 42 yo                              Fundal myoma ~ 7 cm
    Significant bleeding                         3 ablations

           Affecting personal and work life    Posterior / LUS ~ 2 cm
           Wanted return to work quickly       Total IV anesthesia
                                                Procedure time 40 minutes

15 | ML 06072 -001.A

Patient Turned Advocate

16 | ML 06072 -001.A

Firm Fibroid

17 | ML 06072 -001.A

Small Ablation to Soften Fibroid

18 | ML 06072 -001.A

Larger Ablation Post Small Ablation

                                          Introducer advances without
                                           fibroid moving away
                                          Needle Electrodes deploy
                                           smoothly

19 | ML 06072 -001.A

Post Ablations

20 | ML 06072 -001.A

Outcome

21 | ML 06072 -001.A

Candidates for Sonata Procedure Discussion

                  Kelly Roy, MD                  David Levine, MD          David Toub, MD

22 | ML 06072 -001.A