Sonablate vs. Ablatherm · (When HIFU is not firing) Sonablate® 4 (Two for imaging, two for...

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Sonablate ® vs. Ablatherm ® COMPARISON GUIDE Sonablate ® Focal (41) 3 89% 100% 8% 0% Sonablate ® (219) 1 87% 3% 0% 18% 1% Ablatherm ® Hemiablaon (111) 4 78% 97% 12% 0% Ablatherm ® (131) 2 68% 39% 0% 19% 18% CLINICAL DATA 1 Uchida et al. THE JOURNAL OF UROLOGY Vol. 193, 103-110, January 2015 2 EDAP PMA Data, 2014 3 Ahmed et al. Lancet Vol. 13, 622–632, June 2012 4 EDAP Press Release Abstract 109th French Urology Congress, 2015 Sonablate® has 510(K) clearance in the U.S. under a De Novo regulatory grant for the ablation of prostate tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. SonaCareMedical.com Sonablate® First prostate HIFU device cleared in the USA PRIMARY (Number of Subjects) Negave Biopsy Urinary Inconnence (leak) Rectal Fistula (surgical repair) Urethral Stricture Bladder Neck Contracture FOCAL/HEMI (Number of Subjects) Retained Sexual Funcon Maintained Connence Presence of Clinically Significant Disease on Biopsy Rectal Fistula (surgical repair)

Transcript of Sonablate vs. Ablatherm · (When HIFU is not firing) Sonablate® 4 (Two for imaging, two for...

Page 1: Sonablate vs. Ablatherm · (When HIFU is not firing) Sonablate® 4 (Two for imaging, two for therapy) 6.3 mHZ 4 mHZ dual focal lengths (4 cm and 3 cm) Yes (Transducer motion) PROBE

Sonablate® vs. Ablatherm®

CompAriSon Guide

Sonablate®Focal (41)3

89%

100%

8%

0%

Sonablate®(219)1

87%

3%

0%

18%

1%

Ablatherm®Hemiablation (111)4

78%

97%

12%

0%

Ablatherm®(131)2

68%

39%

0%

19%

18%

CLiniCAL dATA

1 Uchida et al. THE JOURNAL OF UROLOGY Vol. 193, 103-110, January 20152 EDAP PMA Data, 20143 Ahmed et al. Lancet Vol. 13, 622–632, June 2012 4 EDAP Press Release Abstract 109th French Urology Congress, 2015

Sonablate® has 510(K) clearance in the U.S. under a De Novo regulatory grant for the ablation of prostate tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

SonaCareMedical.com

Sonablate® First prostate HIFU device

cleared in the USA

primArY(number of Subjects)

Negative Biopsy

Urinary Incontinence (leak)

Rectal Fistula (surgical repair)

urethral Stricture

Bladder Neck Contracture

FoCAL/Hemi(number of Subjects)

Retained Sexual Function

Maintained Continence

Presence of Clinically Significant Disease on Biopsy

Rectal Fistula (surgical repair)

Page 2: Sonablate vs. Ablatherm · (When HIFU is not firing) Sonablate® 4 (Two for imaging, two for therapy) 6.3 mHZ 4 mHZ dual focal lengths (4 cm and 3 cm) Yes (Transducer motion) PROBE

Sonablate®

$450,000

$2,400

300 lbs.

15-20min/20-30min

Ablates 10cc/hr

Yes(SonaCare limits the number of relocations)

Yes(Base console supports multiple probes)

Yes(Sonalink™ provides remote quality control

at no extra charge)

2(Reduces time between cases)

33mm

Degassed water

Lithotomy

Ablatherm®

$750,000

$1,200

950 lbs.

15-20min/20-30min

Ablates 10cc/hr

Yes

no

no

1

36mm

Proprietary gel

Lateral

Sonablate®

Yes

Yes

no

Yes(Current organ position compared

to reference image)

Yes(monitors echogenic change to

prevent critical structure damage)

SAFeTY FeATureSrectal Wall distance monitoring

Rectal Wall Temp. Monitoring

Patient Movement Sensor

Organ Movement Feedback

Reflectivity Index Monitor (RIM)

Ablatherm®

Yes

Yes

Yes(External sensor on patient’s hip)

no

no

Sonablate® is a trademark of SonaCare Medical

Ablatherm® is a trademark of EDAP TMS

SYSTem SpeCSSystem Cost (approx.)

Disposable Cost

Weight

Set Up/Clean Up Time

Treatment Time

Transportable

Multimodality

Tele-monitoring

Probes Included

probe Size

Coupling Medium

Patient Position

Sonablate® vS. ablatherm®

CompariSon Guide

Page 3: Sonablate vs. Ablatherm · (When HIFU is not firing) Sonablate® 4 (Two for imaging, two for therapy) 6.3 mHZ 4 mHZ dual focal lengths (4 cm and 3 cm) Yes (Transducer motion) PROBE

Ablatherm®

none

none

no

nono

Yes(When HIFU is not firing)

Sonablate®

4(Two for imaging, two for therapy)

6.3 mHZ

4 mHZdual focal lengths

(4 cm and 3 cm)

Yes(Transducer motion)

PROBE CHARACTERISTICS

Number of Transducers

Imaging Frequency

Therapy Frequency

Transducer Focal length

Robotic / Motorized

Ablatherm®

2(One for imaging, one for therapy)

7.5 mHZ

3 mHZ

4.5 cm

Yes(Transducer and probe motion)

SoFTWAre FeATureS

Fusion Compatibility

Ablation Monitoring

Power Adjustment (During Ablation)

3D Visualization Automatic Planning Margins

real-Time imaging

Sonablate®

No Restrictions

Ap + (rWT) < 37 mm

pATienT SeLeCTionRectal Wall Thickness (RWT)

Gland AP Limit

Ablatherm®

Must be between 3 mm - 8 mm

Ap < 24 mm

SonaCareMedical.com

Sonablate®

profusemim (Coming Soon)

SmartTarget (Coming Soon)

Tissue Change monitoring (TCm)(Provides physician feedback after

each ablation is fired)

Yes(Customizable to prostate characteristics)

YesYes

no(3 second delay)

Page 4: Sonablate vs. Ablatherm · (When HIFU is not firing) Sonablate® 4 (Two for imaging, two for therapy) 6.3 mHZ 4 mHZ dual focal lengths (4 cm and 3 cm) Yes (Transducer motion) PROBE

1-888-874-4384 SonaCareMedical.com

10130 Perimeter Parkway, Suite 250, Charlotte, NC 28216 MK-217 Version 1.0

Sonablate®

Due to the shorter length of a single lesion, only the region of interest is ablated, resulting in an ablation that spares

the sphincter and pubic bone.

Ablatherm®

A 4mm Safety Margin is “mandatory to avoid burning of the sphincter, and causing patient incontinence”. Due to the longer

length of a single lesion, the pubic bone remains at high risk of injury.

Apex

SpA

rin

G

Sonablate®

Due to the shorter length of a single lesion, the ablation zones can be stacked to conform to the shape of the gland.

Ablatherm®

Due to a greater length lesion and single-row treatment pattern, either the neurovascular bundle may be ablated or

the gland may be under-treated.

Hem

i GLA

nd

ABLATION METHOD COMPARISON (shown on prostate with AP height of 2.8cm)

Sonablate®

Due to the shorter length of a single lesion, only the region of interest is ablated, resulting in a tissue sparing ablation.

Ablatherm®

due to the greater length of a single lesion, there can be a large amount non-targeted tissue ablated.

FoCA

L

keY