brochure Ablatherm NEW 09-06

brochure Ablatherm NEW 09-06-15_UK.qxp
15/06/09
11:09
Page 1
Move up a gear
with ultrasound
technology
T R E AT I N G
LOCALIZED
P R O S TAT E
CANCER
HIFU - High Intensity Focused Ultrasound
www.edap-tms.com
brochure Ablatherm NEW 09-06-15_UK.qxp
15/06/09
11:09
Page 2
Ablatherm HIFU
®
Take control of your new robotic assistant
Real-time visualization
during scanning and firing phases
HIFU
3 MHz EDAP TMS treatment transducer
7.5 MHz B&K imaging transducer
High Intensity Focused Ultrasound
Institut national
de la santé et de la
recherche médicale
Jointly developed by the French National Institute
for Medical Research (INSERM) and EDAP TMS
Safety
Automated safety features
Precise and irreversible coagulation necrosis
Preservation of surrounding tissues
Easy monitoring from
the user-friendly interface
Post HIFU MRI
Versatile
3 treatment protocols (power algorithms)
• First-line treatment
• Repeat treatment
• Salvage treatment after EBRT
Complete, partial or nerve-sparing treatment strategy
Right prostate lobe treatment
Months
20
18
15
Flexible
Early feedback via rapid PSA Nadir
Safety
10
5
3
2
Repeatable if necessary
3-dimensional
(does not increase Gleason score)
Does not preclude other treatment modalities
Computer controlled
movements
HIFU
EBRT
Radical
Prostatectomy
Time to PSA Nadir
Micro steps
Ablapak and Ablasonic
®
®
Patented fluid for optimal
ultrasound transmission
Closed system without contamination risk
Rectal cooling system
Reduce prostate movements
Page 5
Ablatherm HIFU
®
Efficacy
100
Minimally-invasive – Radiation-free
80
Indications
Range published in the
literature since 2000
77%
40
2006 n=58 [9]
2006 n=30 [8]
2004 n=146 [7]
No late onset incontinence
or impotence
[5]
100%
Range published in the
literature since 2000
77%
40
77%
100%
75
[a]
Consistent results in the litterature
5%
EBRT
[b]
Reproducible
and consistent results
25
No late onset incontinence or impotence
2003
Radical [b]
Prostatectomy
2007
[1]
Poissonnier, Lyon
Incontinence
100
[a] excluding grade 1, [b] pad rate. [1] Ficarra et al, BJU Int. 2006
Dec;98(6):1193-8. [2] Chaussy and Thuroff Curr Urol Rep. 2003;4(3):24852. [3] Zelefsky et al, Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):11116; [4] Brabbins et al, Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):400-8.
[5] Steineck et al, N Engl J Med. 2002 Sep 12;347(11):790-6; [6] Abou-Elela
et al, Eur J Surg Oncol. 2007; 33:96-101.
Range published in the
literature since 2000
86% 86%
80
78%
88%
82%
85%
75%
Proven therapeutic choice for local recurrence
after EBRT
Radical [b]
Prostatectomy
[3]
83%
Gelet,
Poissonnier, Lyon
2006 n=58 [9]
2006 n=30 [8]
2004 n=146 [7]
2003 n=175 [6]
Chaussy,
Blana, Ficarra, Lee,
Thüroff, Munich Regensburg Verona Seoul
[6]
14%
13%
EBRT
Radical
Prostatectomy
*87% of patients remain potent with a
nerve-sparing treatment strategy
25
Range published in the
literature since 1995
[1]
43%
[2]
19%
Promising local control with 80% negative biopsies
combined with an acceptable morbidity profile[2]
(No case
reported)
Promising specific survival rate at 5 years: 78%
0%
and 49.5% for low and intermediate-risk patients,
respectively[3]
Negative biopsy rate
[1] Gelet et al, J Endourol. 2000;14(6):519-28; [2] Gelet et al, Eur Urol. 2001;40(2):124-9; [3] Poissonnier et al Prog Urol. 2003;13(1):60-72; [4] Poissonnier et al Eur Urol. 2007;51(2):381-7; [5] Thuroff et al
J Endourol. 2003;17(8):673-7; [6] Chaussy et al Curr Urol Rep. 2003;4(3):248-52; [7] Urology. 2004;63(2):297-300; [8] Ficarra et al BJU Int. 2006;98(6):1193-8; [9] Prostate Cancer Prostatic Dis. 2006;9(4):439-43.
Low morbidity
and consistent clinical results
[2]
25
50%
77%
0
[4]
41%
[1] Blana et al Urology. 2004 Feb;63(2):297-300. [2]Thuroff et al. J Endourol. 2003
Oct;17(8):673-7. [3] Potosky et al, J Natl Cancer Inst. 2000 Oct 4;92(19):1582-92;
[4] Matalinska et al, J Clin Oncol. 2001 Mar 15;19(6):1619-28; [5] Matalinska et al, J Clin
Oncol. 2001 Mar 15;19(6):1619-28; [6] Walsh et al, J Urol. 2000 Jun;163(6):1802-7.
[1] Poissonnier et al Prog Urol. 2003; 13(1): 60-72; [2] Blana et al Eur Urol.
In press 2007.
Reccurent prostate cancer after EBRT is very
aggressive. At least 27% of men with a rising
PSA level after EBRT will die in the next 5 years[1].
HIFU has shown promising results as a salvage
therapy with:
53%
Impotence
Salvage treatment
2003 n=96 [6]
2003 (multicenter) n=402 [5]
2007 n=227 [4]
2003 n=120 [3]
20
2001 n=102 [2]
Published 8-year follow-up and more
40
2000 n=82 [1]
Uniform and reproducible clinical results
[b]
[1]
HIFU
Biochemical disease free rate without
recurrence (T1 – T2 N0 M0) at 5 years
93%
87%
[2]
Blana, Regensburg
60
Efficacy
EBRT
Occurrence %
HIFU
[4]
50
50
Low morbidity
0%
[a]
[a] excluding grade 1, [b] pad rate. [1] Ficarra et al, BJU Int. 2006
Dec;98(6):1193-8. [2] Chaussy and Thuroff Curr Urol Rep. 2003;4(3):24852. [3] Zelefsky et al, Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):11116; [4] Brabbins et al, Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):400-8.
[5] Steineck et al, N Engl J Med. 2002 Sep 12;347(11):790-6; [6] Abou-Elela
et al, Eur J Surg Oncol. 2007; 33:96-101.
91%
Range published in the
literature since 2000
Occurence %
Occurrence %
10
0%
63%
[6]
7% [2]
2,3%
[6]
5%
[4]
Incontinence
[5]
Quality of life
[1]
[1]
7% [2]
2,3%
10
Chaussy,
Blana, Ficarra, Lee,
Thüroff, Munich Regensburg Verona Seoul
[1] Gelet et al, J Endourol. 2000;14(6):519-28; [2] Gelet et al, Eur Urol.
2001;40(2):124-9; [3] Poissonnier et al Prog Urol. 2003;13(1):60-72;
[4] Poissonnier et al Eur Urol. 2007;51(2):381-7; [5] Thuroff et al J Endourol.
2003;17(8):673-7; [6] Chaussy et al Curr Urol Rep. 2003;4(3):248-52;
[7] Urology. 2004;63(2):297-300; [8] Ficarra et al BJU Int. 2006;98(6):1193-8;
[9] Prostate Cancer Prostatic Dis. 2006;9(4):439-43.
75
[3]
[3]
15%
Negative biopsy rate
49%
15%
20
HIFU
Gelet,
Poissonnier, Lyon
Quality of life
20
83%
49%
0
or radical prostatectomy
30
2003 n=175 [6]
Treatment for local recurrence after EBRT
2003 n=96 [6]
20
not suitable for surgery
Range published in the
literature since 2000
85%
30
40
First-line treatment for patients who are
50%
82%
75%
[5]
50%
60
T1 – T2 localized prostate cancer
Quick recovery
Quality of life
93%
87% 88%
2003 (multicenter) n=402 [5]
Spinal or general anaesthesia
78%
2007 n=227 [4]
Short hospital stay (0-3 days)
Range published in the
literature since 2000
86% 86%
State-of-the-art
surgical robotic assistant
Occurrence %
State-of-the-art
surgical robotic assistant
2003 n=120 [3]
11:09
2001 n=102 [2]
15/06/09
2000 n=82 [1]
brochure Ablatherm NEW 09-06-15_UK.qxp
[1] (ref: Sandler et al. Int J Radiat Oncol Biol Phys. 2000;48(3):629-33). [2] (Gelet et al Urology. 2004;63(4):625-9). [3] Recurrent¨Prostate Cancer After Radiotherapy – Salvage treatment by Hign Intensity
Focused Ultrasound. European Oncological Disease 2006 – Issue 1
HIFU
Severe rectal lesions
Fistula < 0.5%[3]
[3]
Literature since 2003.
Poissonnier et al Prog Urol. 2003;13(1):60-72.
0%
EBRT
0%
Radical
Prostatectomy
Moderate rectal lesions
(bleeding, diarrhea, bowel urge)
[1] Shrader-Bogen et al. Cancer. 1997 May 15;79(10):1977-86.
[2] Lim et al J Urol. 1995 Oct;154(4):1420-5.
brochure Ablatherm NEW 09-06-15_UK.qxp
15/06/09
11:09
Page 8
Ablatherm® HIFU
Take control of your
new robotic assistant
Using the latest technology breakthroughs for each treatment step
Treatment start
Treatment preparation
Prostate volume scanning
• B&K imaging transducer
(7.5 MHz / 128 elements electronic array)
• Real-time visualization
• 3D volume reconstruction
Consumable setting: Ablapak®
•
•
•
•
00: 30
Patented fluid for optimal ultrasound transmission
Closed system without contamination risk
Rectal cooling system
Reduces prostate movements
00:10
Safety
Intraoperative treatment planning
Tc
• Variable lesion height: 19 to 26 mm
• Rectum is completely excluded from
the treatment area with a 3 to 8 mm
safety distance
00: 40
Safety
01: 00
First-line treatment
• Clinically validated power algorithms jointly
developed by the INSERM* and EDAP TMS
• Reproducible results
Repeat treatment
01: 30
Salvage treatment
after EBRT
02:00
00:20
*French National Institute for Medical Research
Safety
Accuracy ± 1mm
• Automated and precise treatment
of the targeted volume
• Dynamic adjustment of the focal point
following the rectal wall position
• Real-time visualization
Safety
Automated safety features monitoring
Treatment protocol choice
Institut national
de la santé et de la
recherche médicale
The prostate is fully treated with a single
pass from the anterior to the posterior part
Automated treatment
• No potential interference
of the ultrasound by gas bubbles
• Continuous Ablasonic® fluid degassing
Right lateral
decubitus
B&K
7.5 MHz
Safety
°
Ideal patient positioning
00:15
EDAP TMS
3 MHz
Safety
•
•
•
•
•
Probe position / rectal wall
Rectal wall temperature measurement
Infrared patient movement detection
Robotic mouvement pressure regulator
Power delivered
End of treatment
Safety
brochure Ablatherm NEW 09-06-15_UK.qxp
15/06/09
11:10
Page 10
You Master Urology
We Master
Therapeutic Ultrasound
By consistently investing in research and development and by
forming partnerships with internationally-renowned medical
research institutions, EDAP TMS has been able to patent
innovative technologies.
EDAP TMS is present in many countries via an extensive
network of Subsidiaries and Distribution Partners. The
Company focuses on producing a high standard of service for
health care practitioners: mobile equipment, training centers
and a far-reaching maintenance network.
With Ablatherm® HIFU, EDAP TMS is the world leader in High
Intensity Focused Ultrasound (HIFU) for localized prostate
cancer treatment.
The company is currently adapting this technology so that it is
potentially able to treat other types of tumors.
As a pioneer and key player in the field of extracorporeal
lithotripsy, EDAP TMS introduced the first modular lithotripter
and owns the patent for Electroconductive® technology, utilized
in its Sonolith® range of ESWL systems.
EDAP TMS focuses every day on delivering technologies that
guarantee positive outcomes which are replicable, with low
side effects and a preserved quality of life.
www.edap-tms.com
EDAP TMS – 4, rue du Dauphiné – PA La Poudrette Lamartine – 69120 Vaulx-en-Velin – FRANCE
Tél : +33 (0)4 72 15 31 50 – Fax : +33 (0)4 72 15 31 51 – www.edap-tms.com – [email protected]
ISO 900: 2000
•
ISO 13485: 2003
394 804 447 RCS LYON - EDP 800 008H - June 2009 - All specifications subjet to change without notice. Pictures not binding
EDAP TMS is the leader in therapeutic ultrasound. Having been
present in the market for more than 25 years, EDAP TMS
(NASDAQ: EDAP) develops minimally-invasive therapeutic
solutions for urology.