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