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Prostate Cryotherapy Minimally Invasive Cancer Treatment PM-3590 Rev A 08/11 This information is intended for general patient education purposes only in consultation with a physician.
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What is Cryotherapy? Cryotherapy, Cryoablation, Cryosurgery Cryotherapy, Cryoablation, Cryosurgery –Tissue Ablation (destruction) through the localized delivery of extreme cold Procedure Basics 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 2 PM-3590 Rev A 08/11
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Tissue Effects of Cryoablation 1 Cell membranes are damaged along with intra & extracellular structures Cell membranes are damaged along with intra & extracellular structures Microvascularity destroyed, disrupting oxygen supply to treated tissue Microvascularity destroyed, disrupting oxygen supply to treated tissue Treated tissue necroses (dies) and is replaced by fibrotic mass Treated tissue necroses (dies) and is replaced by fibrotic mass Nerve bundles ablated, however, nerve sheaths remain intact, providing pathway for nerve regeneration Nerve bundles ablated, however, nerve sheaths remain intact, providing pathway for nerve regeneration 1 Baust JG, et al; Current Opinion in Urology 2009, 19:127-132 3 PM-3590 Rev A 08/11
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What will the patient experience? Cryotherapy Minimally invasive, minimal blood loss, no incisions, small probes inserted through the skin in the “bicycle seat” area 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 treatment will take place in the OR, under general or spinal anesthesia The entire treatment including recovery room will be around 6 hours The entire treatment including recovery room will be around 6 hours Recovery Recovery Patients usually go home the same day Patients usually go home the same day A Suprapubic tube (through the skin) or catheter is usually necessary for about 1 to 2 weeks 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 Many patients report little discomfort and often recover fully within days PM-3590 Rev A 08/11 4
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Freezing: 6-8 CryoProbe™ Devices 6-8 Variable/Adjustable length CryoProbes allow freezing of entire gland 6-8 Variable/Adjustable length CryoProbes allow freezing of entire gland Temperature Monitoring within probes Temperature Monitoring within probes No probe over rectum No probe over rectum Argon Gas provides rapid temperature drop Argon Gas provides rapid temperature drop PM-3590 Rev A 08/11 5
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Monitoring: 4-6 TempProbe ® Sensors External SphincterExternal Sphincter Helps preserve continenceHelps preserve continence Denonvillier’s FasciaDenonvillier’s Fascia Prevents freezing of rectumPrevents freezing of rectum Neurovascular Bundles (see previous slide)Neurovascular Bundles (see previous slide) Confirms total gland ablationConfirms total gland ablation Ext. Sphincter Denonvillier’s Fascia PM-3590 Rev A 08/11 6
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Probe Placement: CryoGuide ® System Capture Plan Treat Brachytherapy style planning system assures accurate and complete treatment PM-3590 Rev A 08/11 7
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Clinical Data Summary Avg Follow-Up (months) Number of Patients Timeframe (years) BDFS Failure Basis Rectal Injury IncontinencePotency 31.84099575% ASTRO (3 cons ↑ ) 0.4%3.1% 32% (12 mo) 1 100117773% Phoenix (Nadir + 2) N/A 29% 2 147±3337010 80% (L) 74% (M) 46% (H) Phoenix (Nadir + 2) N/A N/A 3 20.4±14.74164 84% (L) 82% (M) 69% (H) ASTRO (3 cons ↑ ) 0.0%4.0% 51% (48 mo) 4 3565682% (H) ASTRO (3 cons ↑ ) N/A3.1%N/A 5 50765 75% (L) 89% (M) 76% (H) >1.0 ng/mL0.0%1.3% 47% (36 mo) 6 685907 92% (L) 89% (M) 89% (H) ASTRO (3 cons ↑ ) <0.1%4.3% 5% (Unaided) 7 24±16.59755 76% (L) 67% (M) 41% (H) >1.0 ng/mL0.5%7.5% 7% (Unaided) 8 1 Dhar et al, J Urol 2010; 183(4 Supl):e184 Abstract 467. 2 Donnelly et al, Cancer 2010; 116(2):323-30. 3 Cohen et al, Urology 2008; 71(3):515-8. 4 DiBlasio et al, IBJU 2008; 34:443-50. 5 Ellis et al, Urology 2007; 69(2):306-10. 6 Prepelica et al, Cancer 2005; 103(8):1625-30. 7 Bahn et al, Urology 2002; 60(Supl 2A):3-11. 8 Long et al, Urology 2001; 57(3):518-23. PM-3590 Rev A 08/11 8
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Clinical Data Highlights Timeframes up to 10 years 3 Timeframes up to 10 years 3 Over 6,000 patients studied 1-8 Over 6,000 patients studied 1-8 Overall BDFS = 73%-90% 1-8 Overall BDFS = 73%-90% 1-8 Return to potency as high as 51% after 4 years 3 Return to potency as high as 51% after 4 years 3 –Utilized active rehabilitation Rectal injury ≤ 0.5% 1,3,5-8 Rectal injury ≤ 0.5% 1,3,5-8 Incontinence < 8% 1,4-8 Incontinence < 8% 1,4-8 Favorably compares to external beam radiation 2 Favorably compares to external beam radiation 2 1 Dhar et al, J Urol 2010; 183(4 Supl):e184 Abstract 467. 2 Donnelly et al, Cancer 2010; 116(2):323-30. 3 Cohen et al, Urology 2008; 71(3):515-8. 4 DiBlasio et al, IBJU 2008; 34:443-50. 5 Ellis et al, Urology 2007; 69(2):306-10. 6 Prepelica et al, Cancer 2005; 103(8):1625-30. 7 Bahn et al, Urology 2002; 60(Supl 2A):3-11. 8 Long et al, Urology 2001; 57(3):518-23. PM-3590 Rev A 08/11 9
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Cryoablation of the Prostate Before During Probe Placement Frozen PM-3590 Rev A 08/11 10 This information is intended for general patient education purposes only in consultation with a physician.
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