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Spirotome Concept Sales Guide. Version 2012. Spirotome 8-10-14G. Trocar Helix needle Cutting cannula Release element. FIRST Manual V acuum & Macro Biopsy System. CE & FDA Approved for 13 different applications. How it works?. Spirotome Technology. 1.Searching.
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Spirotome Concept Sales Guide Version 2012
Spirotome 8-10-14G • Trocar • Helix needle • Cutting cannula • Release element FIRST Manual Vacuum & Macro Biopsy System CE & FDA Approved for 13 different applications
How it works? Spirotome Technology 1.Searching 2.Penetration 3.Cutting 4.Retrieving
Spirotome Training Program Define Needs Spirotome Solution Identify Customer Relationship Product awareness Product Workshop, Application Fields & Procedure Training Follow Up & Feedback Retain Attract Engage Procedure Support Training Program
European Journal of Cancer Prevention, Vol 13, Issue 6, pp 491-498, 2004 CLINICAL EVIDENCE
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
EXTREME CONDITIONS • Smallbreasts and peripheral tumors • Subcutaneous areas • Subareolardisease • Tumors close to bonyor 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
Head & Neck applications Strong demand for macrobiopsies for molecular biology
Thyroid applications ImicroRNA and Thyroid CancerHoney 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 biopsies With laparoscopic assistance CEUS Liver biopsies under ultrasound Dr. Biguet – CHR – Verviers “Spirotome and microbubles the max for liver diagnostics.” Blind
Gynecological applications Gordts Vulva Cervix Uterus Abdominal Ter Brugge Campo
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
Spirotome Training Program Define Needs Spirotome Solution Identify Customer Relationship Product awareness Product Workshop & procedure training Follow Up & Feedback Retain Attract Engage Procedure Support Training Program
CONCLUSION 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