Click to edit Master title style Spirotome 8-10-14G Trocar Helix needle Cutting cannula Release element FIRST Manual Vacuum & Macro Biopsy System FIRST Manual Vacuum & Macro Biopsy System CE & FDA Approved for 13 different applications
Click to edit Master title style How it works? 1.Searching2.Penetration 3.Cutting4.Retrieving Spirotome Technology
Click to edit Master title style Spirotome Training Program Identify Attract Engage Retain Customer Relationship Product awareness Product Workshop, Application Fields & Procedure Training Follow Up & Feedback Define Needs Training Program Procedure Support Spirotome Solution
Click to edit Master title style SpirotomeSpirotome Physician 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 High quality sample qualified for molecular biology Complete & adequate information is important for a efficient & reliable diagnose and treatment selection Patient 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 Low Overhead Costs : Procedure can be done virtually everywhere (no Operating Room required) No assistance or preparation time is needed (Spirotome Biopsy can be done in less than 10min) High quality tissue sample with exact targeting, avoids false negatives Low Material Cost : Only manually operated (vacuum-assisted) macro biopsy device Full reimbursment for Breast Diagnosis (RIZIV code 688472) Can avoid surgical intervention in delicate procedures. No accessories are needed, in contrast to other vacuum assisted biopsy systems
Click to edit Master title style Spirotome Concept Stakeholders Radiologist/interventionistPathologistOncologist Purchasing Dept - Product - technical advantages - Clinical advanatages - Patient comfort - Pricing / reimbursement - 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 non- reimbursed indications - added value of Spirotome concept in the diagnostic & therapeutic process -- Spirotome is a universal product in various fields
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
MicrocalcificationsMicrocalcifications 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 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
Musceloskeletal 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:
Head & Neck applications Strong demand for macrobiopsies for molecular biology
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.
Liver biopsies Liver biopsies under ultrasound Dr. Biguet – CHR – Verviers “Spirotome and microbubles the max for liver diagnostics.” CEUS 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. Blind
Gynecological applications Vulva Cervix Uterus Abdominal Vulva Cervix Uterus Abdominal Ter Brugge Campo Gordts Ter Brugge H. Laparoscopic staging with a new direct and frontal biopsy instrument. J Gynecologic Surgery 2011; in press.
Importance of stroma for Cervix 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
Click to edit Master title style Spirotome Training Program Identify Attract Engage Retain Customer Relationship Product awareness Product Workshop & procedure training Follow Up & Feedback Define Needs Training Program Procedure Support Spirotome Solution
Click to edit Master title style CONCLUSIONCONCLUSION 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
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