Prostate CryotherapyMinimally Invasive Cancer

Treatment

PM-3590 Rev A 08/11

This information is intended for general patient education purposes only in consultation with a physician.

What is Cryotherapy?• 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

2 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

3 PM-3590 Rev A 08/11

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 08/114

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 08/115

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 08/116

Probe Placement: CryoGuide®

System

Capture

Plan

Treat

Brachytherapy style planning system assures accurate and complete treatment PM-3590 Rev A 08/117

Clinical Data SummaryAvg Follow-Up

(months)Number of

PatientsTimeframe

(years)BDFS

FailureBasis

Rectal Injury

Incontinence Potency

31.8 4099 5 75%ASTRO

(3 cons ↑)0.4% 3.1%

32%(12 mo)1

100 117 7 73%Phoenix(Nadir +

2)N/A N/A 29%2

147±33 370 1080% (L)74% (M)46% (H)

Phoenix(Nadir +

2)N/A N/A N/A3

20.4±14.7 416 484% (L)82% (M)69% (H)

ASTRO(3 cons ↑)

0.0% 4.0% 51%

(48 mo)4

35 65 6 82% (H)ASTRO

(3 cons ↑)N/A 3.1% N/A5

50 76 575% (L)89% (M)76% (H)

>1.0 ng/mL

0.0% 1.3%47%

(36 mo)6

68 590 792% (L)89% (M)89% (H)

ASTRO(3 cons ↑)

<0.1% 4.3%5%

(Unaided)7

24±16.5 975 576% (L)67% (M)41% (H)

>1.0 ng/mL

0.5% 7.5%7%

(Unaided)8

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 08/118

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 08/119

Cryoablation of the Prostate

Before

During Probe

Placement

FrozenPM-3590 Rev A 08/1110

This information is intended for general patient education purposes only in consultation with a

physician.