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Linear focused shockwave therapy
for the treatment of ED
Using shockwaves to treat ED
Worldwide more than 160 million of men
suffer from ED.(1)
German data: 19% of men are affected(2)
2% (aged 30 – 39 years)
10% (aged 40 – 49 years)
16% (aged 50 – 59 years)
34% (aged 60 – 69 years)
53% (aged 70 – 79 years)
1.Krane RJ. Clinical challenges. Symposium – New perspectives in the
management of female sexual dysfunction. Boston, 1998 10 23.
2.Braun et.al.
Epidemiology of erectile dysfunction: results of the Cologne Male Survey.
In: Int J Impot Res
12 (2000), Nr. 6, pp.305–11
The continued development of the piezo shockwave technology along with
the use of a therapy source with an extended linear therapy focus has led
to a decisive breakthrough in the search for ways of using shockwaves to
treat vascular erectile dysfunction. Used in combination with the new,
optimized therapy concept LSTC-ED, the application technique and
therapy outcomes have improved significantly.
We have developed a solution.
It is innovative and nothing short of
groundbreaking!
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Not just magic!
A first line
EAU treatment
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
We have developed a solution.
Based on the PiezoWave2 ED
linear shaped focused Shockwave!
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
IPad
Option
Pulse energy: 15.45mJ – this is 23 times the pulse energy of the standard
point focused F10G4 piezoelectric therapy source of the PiezoWave2
Therapy area (x y): 170mm2 – this is 19 times the therapy area of the
standard point focused F10G4 piezoelectric therapy source of the
PiezoWave2
Therapy volume (x y z): 2476 mm3 – compared to the standard point
focused F10G4 piezoelectric therapy source of the PiezoWave2, this
amounts to an increase in the volume of treated area by a factor of 40-50.
(Comparison of pulse energy and therapy source at 11MPa. Treatment volumes are compared
based on maximum values)
Therapy Source FBL10x5G2
Existing
Treatment Options
- PDE-5 inhibitors
- Injections (cavernous body auto-injection therapy)
- Vacuum pumps
- …
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
PDE-5 inhibitors
Three medicines taken by mouth are approved for the treatment
of erectile dysfunction:
Sildenafil (Viagra)
Vardenafil (Levitra)
Tadalafil (Cialis)
These drugs all work equally well.
All three are known as phosphodiesterase-5 (PDE5) inhibitors.
By blocking the PDE-5 enzyme, these drugs help the smooth muscles
of the penis to relax and increase blood flow.
PDE5 inhibitors are generally the first choice of treatment
for erectile dysfunction.
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Intracavernous injection therapy is the process
whereby a small amount of a chemical (prostaglandin E1)
is injected directly into the corpora cavernosa.
These chemicals are smooth muscle relaxants and thus
help increase blood flow into the penis. The advantage
of injection therapy is that it does not depend on oral
absorption, as pills do, and does not depend on
absorption through the tissues, as with intraurethral drugs.
Potential
Disadvantages and Problems
- PDE5-i side effects
- Only treats the symptoms
- Expensive
- No sexual spontaneity
- Decreased self-confidence
- Psychological stress
- …
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Potential
Disadvantages and Problems PDE
PDE5 inhibitors are a good choice for men at any age who are in
good health and who do not have conditions that preclude taking them.
However, PDE5 inhibitors are not suitable for everyone.
Men who take nitrate drugs for angina, or certain types of alpha-blockers
for high blood pressure and benign prostatic hyperplasia,
should not take PDE5 inhibitors. The PDE5 inhibitors are less effective in men
with diabetes and in men who have been treated for prostate cancer.
Men with the following conditions should not take PDE5 inhibitors
without the recommendation of their doctors and even then should use them
with caution:
• Severe heart disease, such as unstable angina, a recent heart attack, or arrhythmias.
• Recent history of stroke
• Hypotension (very low blood pressure)
• Uncontrolled hypertension (high blood pressure)
• Uncontrolled diabetes
• Severe heart failure
• Retinitis pigmentosa. (With this genetic disease, people do not produce phosphodiesterase-5 and do not respond to PDE5 inhibitors.)
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Potential
Side effects
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Common side effects of PDE inhibitors include
• rubescence
• upset stomach
• headache
• nasal congestion
• back pain
• dizziness
• etc.
Rarely reported are serious sides effects like
• heart attack
• visual effects
• hearing loss
• interaction with other drugs
• etc.
Erectile Function
Healthy blood vessels matter!
Erection is the result of a complex synergy
between blood vessels, the nervous system,
hormones and muscles. During an erection
there is increased blood flow to the penis,
which in turn increases the pressure.
Sufficient blood flow to the cavernous bodies
plays an most important role in erectile
function.
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Reduced arterial inflow reduces venous compression,
resulting in an insufficient erection. Arteriosclerosis is one
of the most common causes of ED.
Arterial Factors in Erectile Function!
Risk factors
Chronic nicotine abuse
Diabetes mellitus
High blood pressure
High blood cholesterol levels
Chronic renal disease
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
LSTC-ED®
A unique therapy concept
Treatment of erectile dysfunction using
linear focused piezo shockwaves.
non invasiv
Long-lasting effect
Treats the cause,
not just the
symptoms
new
effectiv
Scientifically
proven simple, painless
application
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
LSTC-ED®
What can the
patient expect
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Original slide
ESSM 15
Dr.
Hatzichristou
Treatment
Treatment is carried out on an outpatient basis without
anesthesia. It is painless and only takes a few minutes.
The therapy head is positioned above the cavernous bodies
and moved longitudinally along the penis.
Treatment should be administered once or twice a week;
a full course of treatment is 4-6 sessions.
There are no known side effects.
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Treatment Technique
The LSTC-ED technique is a quick and comprehensive
treatment covering the entire cavernous bodies. The therapy
source is placed at right angles to the cavernous bodies and
moved longitudinally along the penis (the cavernous bodies)
and the perineum (crura of the penis). This results in
maximum, homogeneous transfer of energy; treatment is
quick and lasts only a few minutes.
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Cross-section
Urethra Cavernous
bodies
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Experience:
Adjust the intensity to 15-20 and frequency to 8 Hz, use
suitable gelpad to set the penetration depth to 10-15 mm.
To avoid air bubbles use Elvation shockwave gel.
Using the LSTC technique slowly move the PiezoWave2
linear probe oriented transversely over the treatment
areas. Apply 2000 shocks on the perineum (both crus
penis) + 2000 shocks on dorsum penis (both corpus
cavernosum). A special penile holder facilitates treatment
delivery. With this technique one session with a total of
4000 shocks (New protocol shows even 5000shocks will
guarantee full target tissue therapy coverage.
Repeat approx. 4-6 times at weekly intervals.
All types of application are possible with PiezoWave2
- Point focus
- Linear focus
- LSTC-ED (most advanced)
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Application Brochures
(Please use both brochures to
get full information)
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
The Mechanism of Action!
Mechanical stimuli can influence many of the cellular functions
of living tissue. Extracorporeal shockwaves – an established
treatment in modern medicine for more than 30 years –
function as mechanical stressors which trigger biochemical
changes in living tissue.
ED-specific Effect:
Angiogenesis (vascularization)
Improved microcirculation
Relaxation of muscles
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Before
After average
After max
Credibility and evidence are
important to us
A multicenter, placebo-controlled study of 75
patients found that treatment was successful
in
81.3%
of patients, as measured and defined by
IIEF scores.
Treatment of Erectile Dysfunction with PiezoWave2 Device. Application of Low Intensity Shockwaves Using Novel Linear Shockwave
Tissue Coverage (LSTC-ED®) technique. A Prospective, Multicentric, Placebo-controlled Study.
Dr. Motil I. 1, Dr.Kubis I. 2, Dr. Sramkova T. 3
4.2 Points
10.0 Points
IIEF
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Initial Studies
Related to focus shockwaves –
not specifically to Piezo Shockwaves
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
Piezo
Shockwave LSTC-ED
Studies/Publications
Major study with 75
Patients is not
published yet
Innovative
treatment
of causes,
not symptoms
Simple
Painless
Outpatient -
treatment
Trustworthy
and
scientifically
proven
LSTC-ED
A comprehensive
Treatment
For a better
quality-of-life
and
greater spontaneity
Effect
lasts
several
months up to years
Emotion
Treatment
options
Anatomy Causes of ED LSTC-ED a new form
of treatment
Scientific
validation
02 03 05 0704 06
Intro
01
We have developed a solution.
It is innovative and nothing short of
groundbreaking!
Elvation Medical GmbH
Ludwig-Wolf-Str. 6
75249 Kieselbronn-Germany
+497231-563656 tel
+497231-563646 fax
info@elvation.de
www.elvation.de

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Tài liệu về máy PIEZOWAVE2 - Công nghệ sóng xung kích tuyến tính

  • 1. Linear focused shockwave therapy for the treatment of ED
  • 2. Using shockwaves to treat ED Worldwide more than 160 million of men suffer from ED.(1) German data: 19% of men are affected(2) 2% (aged 30 – 39 years) 10% (aged 40 – 49 years) 16% (aged 50 – 59 years) 34% (aged 60 – 69 years) 53% (aged 70 – 79 years) 1.Krane RJ. Clinical challenges. Symposium – New perspectives in the management of female sexual dysfunction. Boston, 1998 10 23. 2.Braun et.al. Epidemiology of erectile dysfunction: results of the Cologne Male Survey. In: Int J Impot Res 12 (2000), Nr. 6, pp.305–11
  • 3. The continued development of the piezo shockwave technology along with the use of a therapy source with an extended linear therapy focus has led to a decisive breakthrough in the search for ways of using shockwaves to treat vascular erectile dysfunction. Used in combination with the new, optimized therapy concept LSTC-ED, the application technique and therapy outcomes have improved significantly. We have developed a solution. It is innovative and nothing short of groundbreaking! Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 4. Not just magic! A first line EAU treatment Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 5. We have developed a solution. Based on the PiezoWave2 ED linear shaped focused Shockwave! Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01 IPad Option Pulse energy: 15.45mJ – this is 23 times the pulse energy of the standard point focused F10G4 piezoelectric therapy source of the PiezoWave2 Therapy area (x y): 170mm2 – this is 19 times the therapy area of the standard point focused F10G4 piezoelectric therapy source of the PiezoWave2 Therapy volume (x y z): 2476 mm3 – compared to the standard point focused F10G4 piezoelectric therapy source of the PiezoWave2, this amounts to an increase in the volume of treated area by a factor of 40-50. (Comparison of pulse energy and therapy source at 11MPa. Treatment volumes are compared based on maximum values) Therapy Source FBL10x5G2
  • 6. Existing Treatment Options - PDE-5 inhibitors - Injections (cavernous body auto-injection therapy) - Vacuum pumps - … Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 7. Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01 PDE-5 inhibitors Three medicines taken by mouth are approved for the treatment of erectile dysfunction: Sildenafil (Viagra) Vardenafil (Levitra) Tadalafil (Cialis) These drugs all work equally well. All three are known as phosphodiesterase-5 (PDE5) inhibitors. By blocking the PDE-5 enzyme, these drugs help the smooth muscles of the penis to relax and increase blood flow. PDE5 inhibitors are generally the first choice of treatment for erectile dysfunction.
  • 8. Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01 Intracavernous injection therapy is the process whereby a small amount of a chemical (prostaglandin E1) is injected directly into the corpora cavernosa. These chemicals are smooth muscle relaxants and thus help increase blood flow into the penis. The advantage of injection therapy is that it does not depend on oral absorption, as pills do, and does not depend on absorption through the tissues, as with intraurethral drugs.
  • 9. Potential Disadvantages and Problems - PDE5-i side effects - Only treats the symptoms - Expensive - No sexual spontaneity - Decreased self-confidence - Psychological stress - … Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 10. Potential Disadvantages and Problems PDE PDE5 inhibitors are a good choice for men at any age who are in good health and who do not have conditions that preclude taking them. However, PDE5 inhibitors are not suitable for everyone. Men who take nitrate drugs for angina, or certain types of alpha-blockers for high blood pressure and benign prostatic hyperplasia, should not take PDE5 inhibitors. The PDE5 inhibitors are less effective in men with diabetes and in men who have been treated for prostate cancer. Men with the following conditions should not take PDE5 inhibitors without the recommendation of their doctors and even then should use them with caution: • Severe heart disease, such as unstable angina, a recent heart attack, or arrhythmias. • Recent history of stroke • Hypotension (very low blood pressure) • Uncontrolled hypertension (high blood pressure) • Uncontrolled diabetes • Severe heart failure • Retinitis pigmentosa. (With this genetic disease, people do not produce phosphodiesterase-5 and do not respond to PDE5 inhibitors.) Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 11. Potential Side effects Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01 Common side effects of PDE inhibitors include • rubescence • upset stomach • headache • nasal congestion • back pain • dizziness • etc. Rarely reported are serious sides effects like • heart attack • visual effects • hearing loss • interaction with other drugs • etc.
  • 12. Erectile Function Healthy blood vessels matter! Erection is the result of a complex synergy between blood vessels, the nervous system, hormones and muscles. During an erection there is increased blood flow to the penis, which in turn increases the pressure. Sufficient blood flow to the cavernous bodies plays an most important role in erectile function. Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 13. Reduced arterial inflow reduces venous compression, resulting in an insufficient erection. Arteriosclerosis is one of the most common causes of ED. Arterial Factors in Erectile Function! Risk factors Chronic nicotine abuse Diabetes mellitus High blood pressure High blood cholesterol levels Chronic renal disease Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 14. LSTC-ED® A unique therapy concept Treatment of erectile dysfunction using linear focused piezo shockwaves. non invasiv Long-lasting effect Treats the cause, not just the symptoms new effectiv Scientifically proven simple, painless application Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 15. LSTC-ED® What can the patient expect Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01 Original slide ESSM 15 Dr. Hatzichristou
  • 16. Treatment Treatment is carried out on an outpatient basis without anesthesia. It is painless and only takes a few minutes. The therapy head is positioned above the cavernous bodies and moved longitudinally along the penis. Treatment should be administered once or twice a week; a full course of treatment is 4-6 sessions. There are no known side effects. Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 17. Treatment Technique The LSTC-ED technique is a quick and comprehensive treatment covering the entire cavernous bodies. The therapy source is placed at right angles to the cavernous bodies and moved longitudinally along the penis (the cavernous bodies) and the perineum (crura of the penis). This results in maximum, homogeneous transfer of energy; treatment is quick and lasts only a few minutes. Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01 Cross-section Urethra Cavernous bodies
  • 18. Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01 Experience: Adjust the intensity to 15-20 and frequency to 8 Hz, use suitable gelpad to set the penetration depth to 10-15 mm. To avoid air bubbles use Elvation shockwave gel. Using the LSTC technique slowly move the PiezoWave2 linear probe oriented transversely over the treatment areas. Apply 2000 shocks on the perineum (both crus penis) + 2000 shocks on dorsum penis (both corpus cavernosum). A special penile holder facilitates treatment delivery. With this technique one session with a total of 4000 shocks (New protocol shows even 5000shocks will guarantee full target tissue therapy coverage. Repeat approx. 4-6 times at weekly intervals.
  • 19. All types of application are possible with PiezoWave2 - Point focus - Linear focus - LSTC-ED (most advanced) Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 20. Application Brochures (Please use both brochures to get full information) Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 21. The Mechanism of Action! Mechanical stimuli can influence many of the cellular functions of living tissue. Extracorporeal shockwaves – an established treatment in modern medicine for more than 30 years – function as mechanical stressors which trigger biochemical changes in living tissue. ED-specific Effect: Angiogenesis (vascularization) Improved microcirculation Relaxation of muscles Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 22. Before After average After max Credibility and evidence are important to us A multicenter, placebo-controlled study of 75 patients found that treatment was successful in 81.3% of patients, as measured and defined by IIEF scores. Treatment of Erectile Dysfunction with PiezoWave2 Device. Application of Low Intensity Shockwaves Using Novel Linear Shockwave Tissue Coverage (LSTC-ED®) technique. A Prospective, Multicentric, Placebo-controlled Study. Dr. Motil I. 1, Dr.Kubis I. 2, Dr. Sramkova T. 3 4.2 Points 10.0 Points IIEF Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 23. Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 24. Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01 Initial Studies Related to focus shockwaves – not specifically to Piezo Shockwaves
  • 25. Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01 Piezo Shockwave LSTC-ED Studies/Publications Major study with 75 Patients is not published yet
  • 26. Innovative treatment of causes, not symptoms Simple Painless Outpatient - treatment Trustworthy and scientifically proven LSTC-ED A comprehensive Treatment For a better quality-of-life and greater spontaneity Effect lasts several months up to years Emotion Treatment options Anatomy Causes of ED LSTC-ED a new form of treatment Scientific validation 02 03 05 0704 06 Intro 01
  • 27. We have developed a solution. It is innovative and nothing short of groundbreaking! Elvation Medical GmbH Ludwig-Wolf-Str. 6 75249 Kieselbronn-Germany +497231-563656 tel +497231-563646 fax info@elvation.de www.elvation.de