MED_Spirotome-Concept

Report
Spirotome Concept Sales
Guide
Version 2012
8-10-14G
ClickSpirotome
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• Trocar
• Helix needle
• Cutting cannula
• Release element
CE & FDA Approved for 13
different applications
FIRST Manual
Vacuum & Macro
Biopsy System
it works?
Click toHow
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Spirotome Technology
1.Searching
3.Cutting
2.Penetration
4.Retrieving
Spirotome
Training
Program
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Procedure
Support
Identify
Customer
Relationship
Product awareness
Product Workshop,
Application Fields &
Procedure Training
Follow Up &
Feedback
Engage
Spirotome
Solution
Attract
Retain
Define
Needs
Training
Program
Define Needs: Radiologist is team player
Spirotome
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Physician
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Full control during the procedure. NO shooting or ballistic effect, avoiding vital or impenetrable organs to
be accidentally touched (for example lungs, vascular vessels or bones )
High visibility for an improved targeted navigation
Single insertion biopsy technique
No collateral damage and lower complication rates
High quality sample with a maximal tissue / needle ratio (up to 300mg)
Easy to handle and to fix into the lesion. Accessible to superficial, deeper and delicate lesions.
No cell spreading by shooting effect
Compatible and highly efficient solution for different imaging techniques (Ultrasound, CT, MRI ,
Stereotactic Mammography …)
Pathologist
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High quality sample qualified for molecular biology
Complete & adequate information is important for a efficient & reliable diagnose and treatment selection
Patient
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More efficient treatment selection thanks to a targeted high quality tissue sample within a shorter delay
Virtually painless, silent and patient friendly procedure
Minor bleeding & minor risk for infections
Reliable diagnosis without surgery (local anesthesia)
Cost-efficiency
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Low Overhead Costs :
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Procedure can be done virtually everywhere (no Operating Room required)
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No assistance or preparation time is needed (Spirotome Biopsy can be done in less than 10min)
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High quality tissue sample with exact targeting, avoids false negatives
Low Material Cost :
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Only manually operated (vacuum-assisted) macro biopsy device
•
Full reimbursment for Breast Diagnosis (RIZIV code 688472)
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Can avoid surgical intervention in delicate procedures.
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No accessories are needed, in contrast to other vacuum assisted biopsy systems
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Spirotome
Concept
Stakeholders
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Radiologist/interventionist
- Product - technical advantages
- Clinical advanatages
- Patient comfort
- Pricing / reimbursement
Pathologist
Oncologist
Purchasing Dept
- TISSUE is the ISSUE
-Superior tissue sample
quality
- opening gates to
molecular biology
- personalized
diagnostics
-More efficient
treatment selection
- increase success-rate
of targeted treatments
- personalized therapy
-Pricing
- reimbursed vs nonreimbursed indications
- added value of
Spirotome concept in the
diagnostic & therapeutic
process
-- Spirotome is a universal
product in various fields
The Spirotome
European Journal of Cancer Prevention, Vol 13, Issue 6, pp 491-498, 2004
CLINICAL EVIDENCE
Dr. Melcior Sentis (Barcelona)
SPIROTOME
ON STEREOTACTIC TABLE
MRI CONDITIONAL

Certified testing on Tesla 3:
◦ ASTM F2052 for
displacement force
◦ ASTM F2213 for induced
torque
◦ ASTM F2182 for induced
heating
◦ ASTM F2119 for image
artifact


Clinical tests show no
interference nor safety
issues.
Image artifact lower with
Teflon trocar
Solved problems
of the needle point
1 cm before the receiving
space
 0.5 to 0.7 cm ø
 System 3 cm under the skin
 Lateral uptake: out of target
= > 6 to 24 samples

Microcalcifications
Harries R, Lawson S, Bruckers Liesbeth. Assessment of microcalcifications with limited number of
high-precision macrobiopsies. Eur J Cancer Prev 2010; 19: 374-8.
EXTREME CONDITIONS


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
Small breasts and
peripheral tumors
Subcutaneous areas
Subareolar disease
Tumors close to bony or
delicate structures
Health Care System
No capital investment
 On the average 1
macrobiopsy per week ?
 Affordable biopsies = more
experience = broadening of
indications
 Indication:
BIRADS 4 LESIONS

CONVINCING ?
Benefits for:
 Patient
 Pathologist
 Oncologist
 Operator
 Health Care System
Lung applications
JL Gielen, AM De Schepper, M Blom, P Van Dyck, D Creytens, J Veryser, J Somville, PM Parizel.
Experience with a novel frontal core biopsy device in soft tissue and bone lesions.
Skeletal Radiol 2011; 40:
Musceloskeletal applications
Strong demand for macrobiopsies
for molecular biology
Head & Neck applications
Thyroid applications
ImicroRNA and Thyroid Cancer
Honey Reddi, Ph.D., Assistant Professor, Medicine, Mayo Clinic
Thyroid cancer accounts for 96% of endocrine malignancies affecting
about 3 million individuals in the U.S.
Pre-operative assessment of thyroid nodules by currently used cytological
methods poses a significant clinical challenge due to a 20% non-diagnostic rate.
This results in unnecessary surgical intervention, wherein only 8-17% of cases
are malignant, thereby prompting the need for additional methods of detection.
Lymph node applications
- Breast cancer: axillary node
- Staging of any cancer
- Cancer of unknown primary
- PET-CT follow-up
Liver biopsy
D Nasr, LL Bidot, M Roche, S Paveliu, P Morel, A Naouri, E Odet, P Esquis, F Pilleul, P
Bernard. Maladie des complexes de von Meyenburg (micro-harmatomes biliaires)
découverte lors d’une chirurgie laparoscopique (Spirotome): à propos de deux
observations. Von Meyenburg disease found during laparoscopic surgery
(Spirotome): report of two cases. Annales de Chirurgie 131: 468470, 2006.
With laparoscopic assistance
M, Barbaret V, Chiers K, Duchateau L, Bacci B, Terragni R,
Rossi F, Sounders JH. Evaluation of a manual biopsy device
(«Spirotome ») on fresh canine organs : liver, spleen and
kidneys and first clinical experience in animals. Eur J Cancer
Prev 2011; 20: 140-5.
Liver biopsies
CEUS
Liver biopsies under ultrasound
Dr. Biguet – CHR – Verviers
“Spirotome and microbubles the max for
liver diagnostics.”
Vulva
Cervix
Uterus
Abdomen
Uniqueness
Deeper s a moles
Deeper s a mples
Deep biops ies
Deep biops ies
Primary call points
Gynecologis ts
Gynecologis ts ,
oncologis ts ,
ra diothera pis ts
Gynecologis ts ,
IVF,
Gynecologis ts
Strategy
Complete
dia gnos is
Importa nce of
s troma l fa ctors
Importa nce of
tra ns ition zone
Importa nce of
deep biops ies
Opportunity
new concepts in
gynecology
New concepts in
gynecology, les s
des truction,
pa infree
New concepts in
s troma l fa ctors
new concepts in
s ta ging
la pa rotomy
Predicate device
Punch
Forceps
Forceps
Forceps
Challenges
ha bits
ha bits
ha bits
Combina tion
with endos copes
Ter Brugge H. Laparoscopic staging with a
new direct and frontal biopsy instrument.
J Gynecologic Surgery 2011; in press.
Gynecological applications
Cervicore: Key to Terra Incognita
Sahebali S, Van den Eynden G, Murta E, Michelin M,
Cusumano P, Petignat P, Bogers J.
Stroma issues in cervical cancer: a review of the
role and function of basement membrane, stroma,
immune response and angiogenesis in cervical
cancer development.
Eur J Cancer Prev 2010; 19: 204-215
Importance of stroma for Cervix
Spirotome
Training
Program
Click to
edit Master
title style
Procedure
Support
Identify
Customer
Relationship
Product awareness
Product Workshop &
procedure training
Follow Up &
Feedback
Engage
Spirotome
Solution
Attract
Retain
Define
Needs
Training
Program
Click to CONCLUSION
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Implementing clinical use of personalized diagnostics can stratify patients,
give molecular classification of disease, determine the likelihood of occurrence,
and recommend the best course of treatment. These approaches promise to reduce costs in healthcare,
improve treatment, and have the potential to provide consumer-driven access to health information.
But how will we acquire tissue to fulfill all these opportunities ? Cambridge Healthtech Institute
Thank you for your attention !
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B-3500 Hasselt
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fax: +32 (0)11 283677
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