LS 04633-017| 1 Welcome! Stan Van Gent, Gynesonics
LS 04633-017| 1
Welcome!
Stan Van Gent, Gynesonics
LS 04633-017| 2
Housekeeping
Webinar defaults to everyone on MUTE at start
We will turn OFF the mute for everyone at this time
Please MUTE yourself at your end, so you have control and to avoid background noise and feedback
At any time, please feel free to unmute and ask a question – we are here for you
If you are having any troubles with being heard, please use CHAT function to ask a question
LS 04633-017| 3
Introductions
Physician Educators and Gynesonics Faculty
David Toub, MD
David Levine, MD, Director of MIGS, Mercy – St. Louis Harry Kwan, Director of Clinical Applications
Shane Raine & Frank Constantino, Health Economics & Market Access
Stan Van Gent, Senior Director, Global Marketing
LS 04633-017| 4
Course Objectives
Provide SONATA Clinical Data
Provide detailed information for patient counseling and consent about patient indications and contraindications, and clinical study outcomes
Reimbursement Overview and Updates
LS 04633-017| 5
Course Materials
Course materials in your packet include:
Agenda
FIGO Card
Post Meeting
Link to all presentations, Clinical Compendium of all Sonata Clinical Studies, Sonata Procedure Training Booklet, Sonata Procedure Video
Certificate of completion of Clinical Data, Patient Selection portion of training
When possible, make arrangements for Sonata Procedure Hands On portion of training
LS 04633-017| 6
Gynesonics Remote Activities
To meet the increasing demand for training and practice support, two major programs are being pioneered utilizing remote/virtual technology
1. Virtual training for all didactic, patient selection and case discussion modules of the Sonata training
2. Acceleration of patient education webinars. These will be tightly geofenced around trained physician’s locations
LS 04633-017| 7
Agenda for Today
Welcome Stan Van Gent
Dr. Chudnoff Sonata® Procedure Video
Sonata® System Overview Harry Kwan
Clinical Trial Results David Toub, MD
Patient Selection, Expectations, and Experience, Case Discussion David Levine, MD
Reimbursement and Market Access Shane Raine / Frank Constantino
Wrap-Up Stan Van Gent
LS 04633-017| 8
Dr. Chudnoff Sonata® Procedure Video
LS 04633-017| 9
Sonata Procedure Didactic TrainingSonography-Guided Transcervical Fibroid Ablation
Harry Kwan, Gynesonics
LS 04633-017| 10
Intended Use
The Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
LS 04633-017| 11
Treatable Fibroid Types
Submucous
Intramural
Transmural
Subserous
LS 04633-017| 12
Contraindications and
Cautions for Certain Patients
Contraindications:
Current pregnancy
Intratubal implants
Active pelvic infection
Suspected gynecologic malignancy/premalignancy
Intrauterine device (IUD) that can’t be removed prior to procedure
Refer to the Sonata System Operator Manual for complete operating instructions.
Use caution in patients with:
o Nickel allergy
o Coagulopathy
LS 04633-017| 13
Treatment Not Intended for Use If:
Unusually shortened endometrial cavity (< 4.5 cm fundus-to-external os)
Endometrial cavity is abnormal preventing sufficient access
Dispersive Electrodes overlap (very small thighs)
Piercings can’t be removed (abdominal/genital) Implants in lower extremities
LS 04633-017| 14
System Components
SMART
Tablet
RF
Generator
System
Cart
RFA Handpiece (single use)
Two (2) Dispersive
Electrodes
IUUS Probe (reusable)
LS 04633-017| 15
Radiofrequency (RF) Generator
RF Generator
▪ Energy delivered through RFA Handpiece
▪ Dispersive electrodes complete circuit
LS 04633-017| 16
Radiofrequency Ablation
Energy is dispersed through Needle Electrodes
Ablation temperature is 221°F (105°C) Heat is dispersed for tissue treatment in Ablation
Zone
LS 04633-017| 17
SMART Tablet
Ultrasound imaging capabilities
Compatible with Intrauterine Ultrasound Imaging Probe
LS 04633-017| 18
SMART Guide “Setting Margins for Ablation in Real Time”
SMART Guide is a graphical overlay used for:
Planning ablation
Deploying Needles
Preparing to activate RF energy
LS 04633-017| 19
Radiofrequency Ablation
Fibroids were treated transcervically with the Sonata System prior to elective hysterectomy two weeks later.
The treating gynecologist utilized the SMART Guide to target fibroids.
Uteri were sectioned and ablations assessed.
Pathologists found that ablations were located and sized as predicted.
Fibroid B:
4.1 x 3.7 x 3.8 cm
Fibroid A:
2.8 x 2.5 x 2.1 cm
Viable, non-ablated fibroid tissue. Ablated fibroid tissue.
Full Reference: Garza-Leal, JG, Toub, D, León, IH, et al. Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation
results in a closed abdomen setting. Gynecol Surg (2011) 8: 327.
90% fibroid volume ablated 100% fibroid volume ablated
LS 04633-017| 20
Intrauterine Ultrasound (IUUS) Imaging
Imaging from within the uterus
IUUS Tip is within the endometrial cavity
The ALARA principle (exposure of the patient to
ultrasound energy at a level that is As Low As
Reasonably Achievable) should be practiced.
Consult Operator’s Manual for more information.
LS 04633-017| 21
Intrauterine Ultrasound Imaging
IUUS
Probe Tip
Myometrium Fibroid
Serosa
Fluid in
Endometrial
Cavity
LS 04633-017| 22
Intrauterine Ultrasound Imaging
Serosa
Bladder
Fibroid
IUUS Probe Tip
Endometrial
Cavity
LS 04633-017| 23
IUUS Imaging – Introducer and Needle Electrodes
Introducer and Needle Electrode visualization
Introducer in tissue
Needle Electrodes in tissue
LS 04633-017| 24
Ablation Targeting
Ablation Zone Red inner ellipse
Encompass as much fibroid as possible
Thermal Safety Border Green outer ellipse
Must always be inside the uterine serosa
▪ Thermal Safety Border can be positioned up to the serosa▪ It should never cross the serosa
LS 04633-017| 25
Treatment Device Controls
Articulation Lever
NeedleElectrode
Sliders
AblationGuideKnob
Introducer Sliders
LS 04633-017| 26
Treatment Device Controls
LS 04633-017| 27
Essential Safety Steps
1
2
3 Perform Safety Rotations
Thermal Safety Border within the serosa
Align Introducer Tip “Click to Tip”
LS 04633-017| 28
Start Ablation
To start ablation:
Operator steps once on Footswitch (Do not rest foot on it to prevent unintended stop)
OR
Support Staff presses ON/OFF button on RF Generator (not sterile)
LS 04633-017| 29
RF Status - Active
RF is
RF energy is delivered
Temperature is displayed
Energy heats to 221°F (105°C) Ablation Time is displayed
Status bar indicates ablation progress
Ablation size is displayed
LS 04633-017| 30
Treatment Complete: Retract Controls 4-3-2-1
LS 04633-017| 31
Support Staff Responsibilities
Set up Sterile draped table Sonata System set-up
Power ON Cable Connections
Patient preparation Apply Dispersive Electrodes
Procedure Click on Tip Freeze and Store image Press “Ready” after Final Safety
Check
Post-procedure
Disconnect cables Remove Dispersive Electrodes from
patient and inspect skin
Preclean IUUS Probe for reprocessing Dispose of RFA Handpiece Power OFF Sonata System
Wipe down system including Footswitch and Mouse
Wrap and store power cord Store Footswitch Lower System Cart completely
LS 04633-017| 32
LS 04633-017| 33
Review
▪ Intended use
▪ Contraindications
▪ Sonata System Components
▪ Treatment Device controls
▪ SMART Guide
▪ Support Staff role
▪ 3 Essential Safety Steps
LS 04633-017| 34
Essential Safety Steps
1
2
3 Perform Safety Rotations
Thermal Safety Border within the serosa
Align Introducer Tip “Click to Tip”
LS 04633-017| 35
Thank You
Learn more or contact us at www.sonatatreatment.com
LS 04633-017| 36
Sonography-Guided
Transcervical Fibroid Ablation (TFA): Clinical Data
David Toub, MD, MBA, FACOGMedical Director, Gynesonics
37 | ML 06072 -001.C
Transcervical Fibroid Ablation (TFA)
Volumetric, image-guided radiofrequency ablation
Enables optimized ablated volume of targeted fibroid
Avoids multiple passes of energized needles through the serosa
Not a global therapy; can treat the fibroids that are likely to be symptomatic
Incites thermal fixation and coagulative necrosis
Not associated with infarction-related post-embolization syndrome.
38 | ML 06072 -001.C
Intended UseThe Sonata System is intended for diagnostic intrauterine imaging and transcervical treatment
of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
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.
Patient Selection Considerations
Safety and effectiveness with regard to fertility and fecundity after the use of the Sonata System have not been established, and effectiveness in women with
clinically significant adenomyosis has not been established.
Anticipated Postoperative Events and Potential Risks
Anticipated postoperative events include abdominopelvic pain/cramping; back pain; constipation; dizziness/fatigue; headache; fever; malaise;
nausea/vomiting; sloughing and, less commonly, intact expulsion of ablated fibroid tissue per vaginam (particularly after ablation of submucous fibroids),
and vaginal spotting/bleeding/dysmenorrhea. Potential risks associated with fibroid ablation using the Sonata System include: allergic reactions (including
rash) to device materials; bowel or bladder perforation; cervical/vaginal laceration or tear; dysmenorrhea; electrical shock; hematometrium; hemorrhage;
infections: major and minor local and systemic infections, including intrauterine infection; retention of device fragment; skin burn from the dispersion of RF
energy; thrombotic events; unintended injury to the uterus, cervix or vaginal vault, adjacent organs or tissue; unknown risk to future pregnancies; and
complications including death.
To learn more about the Sonata System, visit us at gynesonics.com/sonata-system or sonatatreatment.com
39 | ML 06072 -001.C
Designed to Treat a Wide Range of Fibroid Types (ablates or partially ablates all non-pedunculated fibroids)
The Sonata System is designed to ablate or
partially ablate the target fibroids in GREEN
FIGO Leiomyoma Subclassification System
40 | ML 06072 -001.C
The FAST-EU trial:
12-month clinical outcomes of women
after intrauterine sonography-guided
transcervical radiofrequency ablation
of uterine fibroids.
Brölmann H, Bongers M, Garza-Leal JG et al.
Gynecol Surg. 2016; 13: 27-35.
41 | ML 06072 -001.C
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.
Baseline 3-months 12-months
Time course series on MR, courtesy of Jose Gerardo Garza-Leal, MD
FAST-EU
Clinical Trial
Objective To establish the safety and effectiveness of the Sonata
System in the treatment of symptomatic uterine fibroids
Study Design ▪ 50 patients treated at 7 centers in Europe and Mexico
3-months ▪ 90% of patients had a reduction in menstrual bleeding
12-months
▪ 92% of patients were free from surgical reintervention for heavy menstrual bleeding
▪ 54% mean reduction in menstrual bleeding
▪ 67% mean reduction in fibroid volume
▪ 88% overall patient satisfaction
42 | ML 06072 -001.C
The SONATA Pivotal IDE Trial:
Ultrasound-Guided Transcervical Ablation of
Uterine Leiomyomas
12-Month Results
Chudnoff S, Guido R, Roy K, Levine D, Mihalov L,
Garza-Leal JG. Obstetrics & Gynecology. 2019; 133: 13-22.
Transcervical Radiofrequency Ablation of
Symptomatic Uterine Fibroids:
2-Year Results
Miller CE, Osman KM, J Gynecol Surg
2019; 35:345-349
43 | ML 06072 -001.C
Treatment Summary, Procedure Time, and Length of Stay
Total Fibroids Ablated 442
Mean # Ablated Fibroids per Patient 3.0 (range:1-9)
Mean # Ablations per Fibroid 1.1 ± 0.4
Procedure Time (minutes)(time elapsed from insertion of device to removal of device)
Median
40.0 min Mean
46.9 ± 29.7minLength of Stay (hours)(time elapsed from insertion of device to time of discharge)
Median
2.3 hours
Mean
2.5 ± 1.2 hours
Return to Normal Activity (days)Median
1 day
Mean
2.2 ± 2.2 days
44 | ML 06072 -001.C
Significant Reduction in Menstrual Bleeding
through 12 Months
303.6
175.9159.5
143.8
0
50
100
150
200
250
300
350
Baseline 3M 6M 12M
Mean Pictorial Blood Loss Assessment Chart (PBAC)
All p < 0.001
-39% -48% -51%
▪ 86% of patients reported a reduction in menstrual bleeding at 3 months
post-procedure.
▪ 95% of patients reported a reduction in menstrual bleeding at 12 months
▪ 65% of women reported >50% reduction in menstrual bleeding.
▪ Sonata was effective in patients where their only qualifying fibroid
was one or more intramural type 3.
45 | ML 06072 -001.C
TimepointCumulative Surgical
Reinterventions
Cumulative Surgical
Reintervention Rate
(Kaplan-Meier)
1 Year 1 0.7%
2 Year 7 5.0%
3 Year 11 8.2%
Low Rate of Surgical Reintervention for HMB through 3 Years
46 | ML 06072 -001.C
Significant Improvements in Symptom Severity and
Quality of Life Persist Through 3 Years
All p-values < 0.001
compared to baseline
54.9
26.922.7 22.6 23.7 22.2
40.3
77.9
84.0 84.2 82.7 83.1
0.0
20.0
40.0
60.0
80.0
100.0
Baseline 3M 6M 12M 24M 36M
SSS HR-QoL
47 | ML 06072 -001.C
Safety Profile
▪ No device-related adverse events
▪ 2 procedure-related SAEs; both resolved with no sequelae
▪ DVT 15 days post-procedure
▪ Vaginal discharge with low-grade fever and cramping 28 days post-procedure▪ Overnight hospital stay for antibiotic administration per hospital policy
▪ Cultures negative for infection
48 | ML 06072 -001.C
Long-Term (5-year) Clinical Outcomes of
Transcervical Radiofrequency Ablation
of Uterine Fibroids: The VITALITY Study.
Garza-Leal JG. Long-Term Clinical Outcomes of Transcervical
Radiofrequency Ablation of Uterine Fibroids: The VITALITY
Study. J Gynecol Surg. 2019; 35:19-23.
49 | ML 06072 -001.C
Low Rate of Surgical Reintervention Over 5 Years
17 subjects with mean follow-up of 5.4 years
No surgical reinterventions for HMB in the first 3.5 years
11.8% cumulative surgical reintervention rate over 5 years
50 | ML 06072 -001.C
Bongers M, Quinn SD, Mueller MD,
et al. Evaluation of Uterine Patency
following Sonography-Guided
Transcervical Ablation of Fibroids.
Eur J Obstet Gynecol Reprod Biol.
2019;242:122-125.
OPEN Trial
Objective Characterize incidence of new intrauterine adhesions following
Sonata treatment
Study Design Post-market, prospective, multicenter, single-arm, observational
study in Europe. Indenting fibroid required for inclusion.
• Hysteroscopic assessment at baseline and 6-weeks
Endpoint Incidence of new adhesions at 6 weeks per European Society of
Hysteroscopy adhesion scoring by independent readers
51 | ML 06072 -001.C
OPEN Trial Results:
No Adhesiogenesis After Treatment
37 patients enrolled at 6 sites
Mean patient age: 42.4 ± 7.2 years (range 29-55)
Mean ablated fibroid diameter: 3.2 ± 1.6 cm (range 1-8 cm)
2 patients withdrew prior to follow-up
35 pairs of baseline and follow-up hysteroscopies were evaluated by independent readers.
1 patient video was unevaluable (no agreement in evaluation by any of the 3 independent readers)
34 showed no sign of adhesions after Sonata per agreement in evaluation by 2 independent readers
6 out of 34 patients had apposing submucous fibroids ablated with no resulting adhesions
52 | ML 06072 -001.C
Systematic Review and Meta-analysis of Studies
Radiofrequency Ablation of Uterine Fibroids
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;1507-1517.
OBJECTIVETo examine the evidence regarding typical patient outcomes
with radiofrequency ablation (RFA)
OUTCOMES
FOR ANALYSIS
• Procedure time and patient recovery metrics
• Change in fibroid volume
• Symptom Severity Scores and Health-Related QOL Scores
• Reinterventions
N=32 articles
1283 unique patients
CONCLUSIONS
Radiofrequency ablation (RFA) of uterine fibroids significantly
reduces fibroid volume, provides significant durable improve-
ments in fibroid-related quality of life and is associated with
favorable reintervention rates.
REPORTED KEY
OUTCOMES
LAPAROSCOPIC
APPROACH
TRANSCERVICAL
APPROACH
Mean procedure
time73 min 44 min
Mean time to
discharge10.7 hours 2.5 hours
Mean return to
normal activities9.0 days 3.3 days
Mean time to
return to work6.5 days 3.6 days
53 | ML 06072 -001.C
Summary of Key Outcomes
Outcomes associated with sonography-guided transcervical fibroid ablation
(TFA) to treat symptomatic uterine fibroids:
A significant reduction in mean menstrual bleeding
Low surgical reintervention for HMB through 3 years
No device-related adverse events
Well tolerated by patients with rapid return to normal activity
Significant and durable improvements in fibroid symptoms and health-related
quality of life
54 | ML 06072 -001.C
LS 04633-017| 55
Patient selection & ExpectationsDIPAK DELVADIA, DO
VIRTUA OB/GYNVOORHEES, NJ
David Levine, MD
St. Louis, MO
LS 04633-017| 56
Sonata Contraindications
Active pelvic infection
Presence of one or more intra-tubal (intrauterine) implants for sterilization
Presence of an intrauterine device (IUD), unless removed prior to the introduction of the Sonata treatment device.
Known or suspected gynecologic malignancy or premalignant disorders such as EIN - endometrial intraepithelial neoplasia (atypical endometrial hyperplasia)
Current pregnancy
LS 04633-017| 57
Patient Selection Considerations
Fibroid size Published experience includes fibroids 7-8 cm Fibroids ≥ 6 cm require multiple ablations to optimize volume reduction
Number of fibroids - up to 10 fibroids were ablated/patient during SONATA Trial
Safety and effectiveness regarding 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
Other conditions as stated in the Sonata System Operator’s Manual
LS 04633-017| 58
Fibroid Size and Volume
RF ablation is volumetric
Assume sphere where V = 4/3 πr3
An 8-cm myoma = 268.1 cc but a 9-cm myoma = 381.7 cc (42.4% increase)
5 cm x 4 cm Sonata ablation (largest size) = 41.9 cc
LS 04633-017| 59
Diameter vs. Volume
LS 04633-017| 60
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
• 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 with isolated subserous fibroids
LS 04633-017| 61
Patient Expectations
Setting appropriate expectations is critical to avoiding patient regret and need for potentially-avoided surgical reintervention
Most patients will see improvement in HMB within 3 months
The goal is meaningful improvement in symptoms
This may or may not meet the definition of eumenorrhea (≤ 80 cc MBL)
Important for patients to not expect
Amenorrhea (this is not endometrial ablation)
Immediate results
Patients should be counselled about potential fibroid sloughing
It can result in intermenstrual spotting
LS 04633-017| 62
Perioperative Care
Bladder drainage not mandatory for imaging but helpful for patient comfort Always best for patient to void on her own just before TFA
Antibiotics? As with operative hysteroscopy, no clear need except for other indications (eg, SBE)
In SONATA, 0.7% of patients received prophylaxis
General Anesthesia not required but may be indicated for specific patients Better to have proper airway control if deep sedation is needed for pain control
Postop Patients typically on NSAIDs
Similar expected events to operative hysteroscopy (leukorrhea x days, spotting, cramping)
Postop visit or call as per your customary practice
LS 04633-017| 63
Some Potential Challenges
Small lower uterine segment myoma
Need 2.3 cm of space for minimum ablation size
Large / firm (calcified) myoma
Tight cervix/cervical stenosis
Take extra care to verify intrauterine entry!
Marked anteflexion/retroflexion
LS 04633-017| 64
Lower Uterine Segment Ablations
• Minimum of 2.3 cm distance between endometrial surface and uterine serosa• Smallest ablation size is 2.2 cm x 1.5 cm
Need ≥ 2.3 cm
Serosa
Serosa
LS 04633-017| 65
7 Women, 7 Sonata Stories
LS 04633-017| 66
REIMBURSEMENT FOUNDATIONS
HEALTH ECONOMICS AND MARKET ACCESS
Frank Constantino: Director, Reimbursement and Payer Relations
Shane Raine: HEMA- Sr. Manager Value Based Offers and Payer Relations
LS 04633-017| 67
Sonata US Covered Lives
Market Opportunity
Top Plan Types
300M
LIVES
Commercial182,023,569 (58%)
Medicaid / CHIP 72,438,965 (23%)
Medicare 58,266,514 (19%)
250MCommercial and Medicaid
Total Market 312.7M
Sonata 254.4M
Uninsured: 27M
LS 04633-017| 68
Authorizations – Coding – Payment
SUCCESS
Proper Coding
Policy Review
Claim Submission
Appeal, if Necessary
Peer-to-Peer Review
Patient Charting
Treatment(s) to Date
Pre-Auth Approval
Establish Medical Necessity
LS 04633-017| 69
CODING AND PAYMENT
LS 04633-017| 70
Coding – Physician and Facility
APC 5416 – Level 6 –Gynecologic Procedures
($6,702.85)
0404T Transcervical uterine fibroid(s) ablation with ultrasound guidance,
radiofrequency
Medicare OPS Facility Payment CPT Coding
Transcervical fibroid ablation is typically performed in the hospital outpatient department
LS 04633-017| 71
Charge Letter – Cross Walk
LS 04633-017| 72
Need Assistance?
PRIA
Preauthorization's Claims Submission & Appeals
Patient eligibilityand benefits verification
Precertification/preauthorization assistance
Preauthorization appeal denial assistance
Coding guidance
Claim submission guidance
Claim appeal assistance
LS 04633-017| 73
Disclaimer
The information provided contains general reimbursement information only and is not legal
advice nor is it advice about how to code, complete, or submit any particular claim for payment.
Information provided is not intended to increase or maximize reimbursement by any payer. The
information provided represents Gynesonics’ understanding of current coding and reimbursement policies. Gynesonics disclaims all responsibility related to provider billing. It is
the provider’s responsibility to determine appropriate codes, charges, and modifiers, and submit claims for the services consistent with the payer requirements. Third-party payer policies and
coding requirements vary and are updated and change over time. Providers should check and
verify
current policies and requirements with the payer for any particular patient.
74 | ML 06072 -001.C