The document summarizes the development of an enhanced MRgFUS system for treating uterine fibroids. The new system aims to increase treatment efficacy and safety while allowing for a wider selection of patients. Key enhancements include a fifth transducer position for beam optimization, beam shaping capabilities to overcome anatomical obstacles, and an automated 3D treatment planner. Preliminary results from a multi-center study show the new system achieved high non-perfused volume ratios of 67.8% on average with no serious adverse events reported. The system demonstrates potential for improving treatment of difficult fibroid cases.

1. MRgFUS for uterine fibroids- The
new generation
Y. Inbar, MD
1st
Europian MRI Symposium
Sept. 2011
Sheba Medical Center, Israel

2. Development goals
 Increased treatment efficacy
 Enhance treatment safety
 Wider patient selection

3. An Enhanced System for MRgFUS
Treatment of Uterine Fibroids

4. 11.5 cm
7.3 cm
6.1 cm
8.6 cm
Highest position Lowest position
30 cm2
60 cm2
50 cm2
100 cm2
Former systemCurrent system
• Higher energy density at the focus
• Lower energy density on near &
far field.
Transducer Elevation
The 5th
Degree of Freedom
Transducer automatically moves up or down for an optimal treatment

5.  shaping the beam by closing elements in the transducer, enables to
overcome anatomic obstacles without the need to steer the whole
beam around it. It may allow wider patient selection and greater
treatment volume
Beam shaping – Anatomic Aperture

6. Coronal View
Sagittal View
Beam shaping – Anatomic Aperture

7.  Spots length varies from 10mm to 70mm
 Optimal volumetric packing to maximize treatment volume
 Longer sonications for reduced treatment time
 Steering along the beam
 Higher dose volumes by taking advantage of the residual heating of
the sonication
 Spot size control
Elongated
Nominal
Short
Elongated
Nominal
Short
Spot Formation and Length

8. Automatically arranges spots to cover maximum targeted volume at a
minimal treatment time, while optimizing:
Automatic 3D Treatment Planner
Former Planner New Planner
 Spot types
 LEDRs
 Shapes
 Transducer aperture
 Transducer height
 Interleave mode
 Automatic tilt

9. Movement Detection
After movement
(Current image)
Before movement
(Reference image)
An automatic feature for detecting patient or organ’s movement.

10. Dose Transfer In case of patient movement
 If the patient moved and there is a need to acquire new planning
images, the physician can copy the accumulated thermal dose to the
new MR images based on the re-drawn ROT.
The system automatically computes treatment plan only on regions not treated yet.
Before movement After movement
Manual adjustment

11. Participating Sites
 Israel- Sheba Medical
Center
 Jaron Rabinovici
 Yael Inbar
 Dahlia Admon
 Ariela Siton
 Russia- COGP
 Yulia Kurashvili
 Alexander Stepanov
 France- Tours
 Frédéric Patat
 Aurore Bleuzen
 Morgane Fournier

12. Objective
 To evaluate safety and ablation efficacy
of the ExAblate 2100 UF V2 system
when treating symptomatic uterine
fibroids

13. Study Design
 Prospective, nonrandomized, multi-center
study 40 patients (Israel, Russia, France, England)
 Women with symptomatic uterine fibroids-
UFS-QOL > 21
 MRI confirmed fibroids that are accessible
 1 month f/u- clinical

14. Results
 Data includes 34pts. (41 tx.)- Israel, Russia,
France
- Total treated 37 pts.- 44 treatments.
- 3 pts. Excluded- technical difficulties
 Patient’s Age 29-54y (Av. 44y)
 BMI 19-37 (Av. 25)

15. Results
 Treated fibroid volumes 20-626cc (Av. 226cc)
 No. of fibroid treated 1-5 (Av. 2)
 Fibroid Intensity on T2w images:
- 62.5% (30/48) fibroids- hypointense
- 37.5% (18/48) fibroids- hyperintense
isointense heterogenous

16. Adverse Events
 No SAE
 Minor AE included abdominal pain,
nausea, diarrhea, back pain, fatigue, slight
fever
catheter related urinary symptoms (4)
bleeding (1)
small area of subcutaneous heating from
treatment (1)

17. UF-2
(UF032 Sheba patients)
UF-1
(78Sheba research patients)
No. of
sonications 941 2546
Average Energy 4129J 2546J
Max. Energy 7779J 4800J
Average Energy

18. Non Perfused Volume (NPV) ratio
Average NPV ratio- 67.8 (+/-18.5%)
Hypointense (30)
71.3%
Hyper/isointense (18)
61.8%

19. Non Perfused Volume (NPV) ratio
Stewart et al. Obstet Gynecol 2007-----Av. NPV ratio 21.9% (N=359)
Okada et al. Ultrasound in Obstet Gynecol 2009-----Av. NPV ratio 46.6% (N=287)
Leblang et al. AJR 2010-----Av. NPV ratio 55% (N=80)
Matzko & Trumm, 2nd
MRgFUS Symposium 2010-----Av. NPV ratio 59.1% (N=41)
%
UF2

20. Patient age: 45 years old
Fibroids volume: 140cc
Treatment time: 180 minutes
Symptoms: Heavy menstrual bleeding, blood clots and pain .
Fibroids Intensity: Iso-Intense with bright portion on T2w Images
Results: 75% NPV with no adverse effects
Sagittal T2wSagittal T1w+c
Pre-Treatment
5 axis motion increased
energy density in focus-
allowed treating Hyper Intense
areas.
Sagittal T1w+c
Post treatment
UF032-6001

21. Patient age: 48 years old
Fibroids volume: 240cc
Fibroids Intensity: Iso-Intense on T2w Images
Symptoms: Heavy menstrual bleeding and bulgy belly.
Sonication time: 180min
Results: 91% NPV with no adverse effects
Sagittal T2wSagittal T1w+c
Pre-Treatment
Beam shaping allowed
treating closer to sensitive
organs and reaching the
fibroid’s superior portion.
Sagittal T1w+c
Post treatment
UF032-6005

22. Patient age: 45 years old
Fibroids volume: 120cc
Fibroids Intensity: Hypointense on T2w Images
Symptoms: Frequent urination.
2 y post myomectomy with large scar
Sonication time: 193 min
Results: 83% NPV with no adverse effects
• No-pass zone LEDR- to avoid
sonicating through a transverse
large scar- tilting and aperture
• Sonications through the scar-
with transducer up and without
tilt- low energy density on the
skin
UF032-6020
Sagittal T2w pre tx Sagittal T2w post tx Sagittal T1w+c post txSagittal T1w+c pre tx

23. Adenomyosis
Patient age: 39 years old
Adenomyosis and tiny fibroid
Symptoms- menometrorrhagia
To avoid bowels we used a
salad bowl
Sonication time: 160min
Results: focalAD NPV 79%
tiny fibroid NPV 100%.

24. Conclusions
 The new enhanced MRgFUS system
seems to allow:
- A wider patient selection (bowel loops, scars, fibroid
intensity, etc)
- Increase sonication volumes
- Enable better treatments of hyperintense fibroids
- Maintain the known safety profile of MRgFUS

25. Thank You
 Israel- Sheba Medical
Center
 Jaron Rabinovici
 Yael Inbar
 Dahlia Admon
 Ariela Siton
 InSightec
 Mor Dayan
 Amit Sokolov
 Russia- COGP
 Yulia Kurashvili
 Alexander Stepanov
 France- Tours
 Frédéric Patat
 Aurore Bleuzen
 Morgane Fournier