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Prostate Cryotherapy Minimally Invasive Cancer Treatment. This information is intended for general patient education purposes only in consultation with a physician. Cryotherapy , Cryoablation, Cryosurgery Tissue Ablation (destruction) through the localized delivery of extreme cold.
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Prostate CryotherapyMinimally Invasive Cancer Treatment This information is intended for general patient education purposes only in consultation with a physician. PM-3590 Rev A 08/11
Cryotherapy, Cryoablation, Cryosurgery Tissue Ablation (destruction) through the localized delivery of extreme cold Procedure Basics Ultrasound-Guided 2.4 mm diameter probes percutaneously (without incision) introduced through the perineum Argon used to freeze Helium used to thaw Thermocouple monitoring at key locations What is Cryotherapy? PM-3590 Rev A 08/11
Tissue Effects of Cryoablation1 • Cell membranes are damaged along with intra & extracellular structures • Microvascularity destroyed, disrupting oxygen supply to treated tissue • Treated tissue necroses (dies) and is replaced by fibrotic mass • Nerve bundles ablated, however, nerve sheaths remain intact, providing pathway for nerve regeneration 1Baust JG, et al; Current Opinion in Urology 2009, 19:127-132 PM-3590 Rev A 08/11 3
What will the patient experience? Cryotherapy • Minimally invasive, minimal blood loss, no incisions, small probes inserted through the skin in the “bicycle seat” area • The treatment will take place in the OR, under general or spinal anesthesia • The entire treatment including recovery room will be around 6 hours Recovery • Patients usually go home the same day • A Suprapubic tube (through the skin) or catheter is usually necessary for about 1 to 2 weeks • Many patients report little discomfort and often recover fully within days PM-3590 Rev A 08/11 4
Freezing: 6-8 CryoProbe™ Devices • 6-8 Variable/Adjustable length CryoProbes allow freezing of entire gland • Temperature Monitoring within probes • No probe over rectum • Argon Gas provides rapid temperature drop PM-3590 Rev A 08/11
Monitoring: 4-6 TempProbe® Sensors • External Sphincter • Helps preserve continence • Denonvillier’s Fascia • Prevents freezing of rectum • Neurovascular Bundles(see previous slide) • Confirms total gland ablation Ext. Sphincter Denonvillier’s Fascia PM-3590 Rev A 08/11
Capture Probe Placement: CryoGuide® System Plan Treat Brachytherapy style planning system assures accurate and complete treatment PM-3590 Rev A 08/11 7
Clinical Data Summary 1Dhar et al, J Urol 2010; 183(4 Supl):e184 Abstract 467. 2Donnelly et al, Cancer 2010; 116(2):323-30. 3Cohen et al, Urology 2008; 71(3):515-8.4DiBlasio et al, IBJU 2008; 34:443-50. 5Ellis et al, Urology 2007; 69(2):306-10. 6Prepelica et al, Cancer 2005; 103(8):1625-30. 7Bahn et al, Urology 2002; 60(Supl 2A):3-11. 8Long et al, Urology 2001; 57(3):518-23. PM-3590 Rev A 08/11
Clinical Data Highlights • Timeframes up to 10 years3 • Over 6,000 patients studied1-8 • Overall BDFS = 73%-90%1-8 • Return to potency as high as 51% after 4 years3 • Utilized active rehabilitation • Rectal injury ≤ 0.5%1,3,5-8 • Incontinence < 8%1,4-8 • Favorably compares to external beam radiation2 1Dhar et al, J Urol 2010; 183(4 Supl):e184 Abstract 467. 2Donnelly et al, Cancer 2010; 116(2):323-30. 3Cohen et al, Urology 2008; 71(3):515-8.4DiBlasio et al, IBJU 2008; 34:443-50. 5Ellis et al, Urology 2007; 69(2):306-10. 6Prepelica et al, Cancer 2005; 103(8):1625-30. 7Bahn et al, Urology 2002; 60(Supl 2A):3-11. 8Long et al, Urology 2001; 57(3):518-23. PM-3590 Rev A 08/11 9
Cryoablation of the Prostate Before During Probe Placement This information is intended for general patient education purposes only in consultation with a physician. Frozen PM-3590 Rev A 08/11