1	Cryoplasty and the PolarCath Experience: How and Why It Works and What is the Scientific Evidence? John R. Laird Professor of Medicine Director of the Vascular Center UC Davis Health System
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3	CryoPlasty® Procedure
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5	Current Theories of the Effects of Cooling The theory of the effects of cold therapy on a vessel are: Altered Plaque Response Reduced Elastic Recoil Apoptosis
6	Current Theories of the Effects of Cooling Altered Plaque Response: Cooling causes the interstitial saline to freeze As ice forms and expands microfractures are created that weaken the plaque It is believed that this action contributes to more uniform dilation of the vessel and less medial injury
7	Current Theories of the Effects of Cooling Reduced Elastic Recoil: Cooling induces an alteration of the collagen and elastin fibers This is believed to temporarily reduce vessel elasticity and may protect against elastic recoil
8	Current Theories of the Effects of Cooling Apoptosis Cooling causes smooth muscle cells to eject water Dehydration and subsequent rehydration may trigger an apoptotic response It is believed that this non-inflammatory response may reduce neo-intimal formation
9	Summary of Preclinical Testing
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11	In Vitro Study- Cell Survival Curve
12	Balloon Temperature Curve
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16	9 Month PVD Big Chill IDE Data CVSi™ Peripheral Balloon Catheter System Safety Registry
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18	9 Month PVD Big Chill IDE Data Prospective Multicenter Registry Design Stand-alone dilation with the PolarCath™ Peripheral Dilatation System Treatment of SFA and popliteal stenoses or occlusions - Lesion length <10cm Up to 100 patients Up to 25 sites
19	9 Month PVD Big Chill IDE Data Registry Endpoints Primary endpoints Target Lesion Primary Patency Technical and Procedural Success (Angio and Duplex) Secondary endpoints Serious adverse event rates Maintenance of blood flow at 3 months and 9 months as determined by ABI and extremity arterial Duplex Scan
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21	9 Month PVD Big Chill IDE Data Study Management Principal Investigators John Laird, MD (USA) Giancarlo Biamino, MD (EU) Duplex Core Lab Michael Jaff, DO (Medical Director)
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23	Lesion Length Distribution
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25	Reduced Dissection Rates (clinically significant events)
26	9 Month Clinical Results
27	TASC A (35%)
28	TASC B (25%)
29	TASC C (40%)
30	Duplex Data In addition to the 16 patients that experienced TLR during the 9-month follow-up period, an additional 8 patients were found to have PSV>300cm/s. The combination of hard TLR events and significantly abnormal duplex yields… Primary patency = 73.3% (PSV>300 cm/sec) Primary patency = 70.1% (>2.0 SVR) Primary assisted patency = 94% Secondary patency = 98%
31	Duplex Data
32	ABI Measurements
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34	CryoPlasty^®Therapy IDE Study: Extended Follow-up Of 102 subjects enrolled, 70 study subjects were available for extended follow-up Mean follow-up time (months): 31.3 ± 6.3 Range (min, max): 10.7, 41.2
35	Extended Follow-up Patient Accounting 102 Patients enrolled 2 Patients died before 9 month follow-up 100 Patients available for extended follow-up 20 patients from sites not participating in extended f/u 80 Patients available from remaining sites 4 patients died in extended follow-up time frame 76 Patients available for follow-up 6 patients refused to return for follow-up visits 70 Patients followed
36	Kaplan-Meier
37	Diffuse Disease Decisions To Stent or Not to Stent?
38	Below the Knee Cryoplasty “BTK Chill”
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40	Limb Salvage-TP Restenosis Case#2 78 y/o F with IDDM & lt. foot pain at rest PMH: S/P failed Lt.F-P Bypass S/P TP cutting balloon PTA 4 months prior ABI 0.4
41	Conclusions
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