1. Pathway Jetstream G3: A Rotational Flushing and Aspirating Atherectomy System
William A. Gray MD
Director of Endovascular Services
Associate Professor of Clinical Medicine

2. William A. Gray, MD DISCLOSURES Consulting Fees
AccessClosure, Inc., CoAptus, Inc., Mercator MedSystems, Inc., Ovalis, Inc., Paragon Medical, Inc., Pathway Medical Technologies, Inc., Sage Medical, Inc.
Grants/Contracted Research
Atritech, Inc., Cordis, a Johnson & Johnson company, CREST/ National Institutes of Health, W.L. Gore & Associates, Inc.
Ownership Interest (Stocks, Stock Options or Other Ownership Interest)
AccessClosure, Inc., CoAptus, Inc., Ovalis, Inc., Paragon Medical, Inc., Pathway Medical Technologies, Inc., Sage Medical, Inc.

3. Pathway Jetstream G3™ System
Jetstream® Catheter
Control Pod
Console
Blades “Down”
2.1 mm
Blades “Up”
3.0 mm
OTW 135cm Front Cutting, High Speed Rotational Catheter
.014GW /7F sheath compatible
Differential cutting tip removes all plaque types
Aspiration ports collect plaque & thrombus
Two sizing options (single device)
Integrated system control within the sterile field
Rotational Speed
One-step size expansion
70K rpm (target therapy speed)
Cassette set up and data display outside sterile field 2

4. Pathway PVD study 1st generation device
Purpose: A prospective, single arm, multi-center study to assess performance of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions
Drs. Scheinert and Zeller - co-PIs
172 patients at 9 European centers
100% data monitoring
Angiographic core lab and CEC adjudicated

5. Pathway PVD Study Parameter Result
Demographics (patients)
Mean Age
Female (n=88)
Male (n=84)
71.9 ± 8.4 years
51.2%
48.8%
PVS Treatment Time
3.5 ± 2.4 minutes
Core Lab Analysis (lesions)
Reference Vessel Diameter n=178
Target Lesion Length n= Pre - PVS Diameter Stenosis n=175
Post - PVS Diameter Stenosis n=175
Mean % reduction n=175
3.7 ± 0.8 mm
35.4 ± 25.2 mm
79.1 ± 17.7%
35.6 ± 16.1%
43.5 ± 19.7%
Ankle Brachial Index (patients)
Baseline n=159
30 days n=149
6 months n=138
12 months n=109
0.59 ± 0.21
0.90 ± 0.23
Rutherford Score (patients)
Baseline n=169
30 days n=142
3.0 ± 0.9
1.2 ± 1.4
1.5 ± 1.4
1.5 ± 1.3
Parameter
Result
Major Adverse Events (MAE) within 30 days Death Myocardial Infarction TVR (including TLR) Amputations
0/172 (0%) 0/172 (0%) 0/172 (0%) 2/172 (1.2%) **
Other Device Related Serious Adverse Events within 30 days
Emboli Dissection (C/D/E/F) Perforations Abrupt Closure Target Limb Re-intervention
3/172 (1.7%) 1/172 (0.6%) 0/172 (0%) 1/172 (0.6%) 1/172 (0.6%)
Target Lesion Revascularization (TLR) within 6 months
Freedom from TLR at 6 months
Freedom from TLR at 12 months
25/172 (14.5%)
85%
74%
* Abbreviations: PVS = Pathway PV System; TVR = Target vessel revascularization; TLR = Target lesion revascularization
** Amputations were planned for both patients prior to the revascularization procedure with the Pathway PV System

6. Evolutionary changes in Pathway device Proximal Aspiration Port
Jetstream G2™
Aspiration Ports
Jetstream™

7. Pathway Jetstream G3™ System
G2 NXT
Distal Cutter:
10 Flute Design
G Distal Cutter:
5 Flute Design
54% more efficient at differential cutting compared to Jetstream G2™ NXT*
*Calculated in Blades Down (Bench test data on file at Pathway Medical)

8. **As compared to Jetstream G2™ NXT in bench testing
Pathway Jetstream G3™ System
7 French Compatibility
Optimized Aspiration*
Enhanced Cutting Effectiveness*
JETSTREAM G3 Improvements
Increased Aspiration Efficiency**
11%
Improved differential cutting efficiency (Blades Down)*
54%
*As compared to Jetstream G2™ NXT in bench testing in challenging lesion model
**As compared to Jetstream G2™ NXT in bench testing
Successfully debulk the toughest Calcified lesions with resulting smooth and concentric 4mm lumens
Simple treatment of the most challenging CTOs

9. JETSTREAM G3™ Animation

10. Pathway Jetstream G3™ System
Definitive Therapy for Calcium & CTOs
Excellent differential cutting efficiency
Optimized Cutting tip
Improved torque
Front-end cutting
Active Aspiration
Only atherectomy device with this feature
Minimizes risk of distal embolization
Short Procedure Times
54% Increase in Cutting Efficiency*
Minimal Fluoroscopy /Reduced Lab Time
Simplicity of Operation
Atherectomy and Thrombectomy indications
“Single Device” Solution
Multiple Vessel Sizes
Expandable Blade Technology
Treats disease from SFA to below the knee
All Pathologies
Atheromatous, Calcium and Thrombus
*Compared to Jetstream G2™NXT in Blades Down during bench testing

11. Comparison of device attributes
Calcium
Thrombus
Embolization
Single-sizing
Front-cutting
FoxHollow ++
CSI +
Pathway

12. Dr. Ivan Casserly: Denver CO
November 6, 2009
Jetstream G3™
Runtime: 9:45 mins
Right SFA Occlusion
Post Jetstream G3™
1 pass B/D
2 passes B/U
16cm Restenotic chronic total occlusion, crossed with a straight glide wire/glide cath
Final after PTA, full balloon
expansion at 3 atm’s IC

13. Dr. Malcolm Foster: Knoxville TN
December 15, 2009
Superficial Femoral
Artery
Jetstream G3™
Runtime: 2:40 mins
Post Jetstream G3™
2 Blades Up Passes
Stand alone result
5cm CTO
1 Blades Down Pass IC

14. IVUS: Concentric 4.0mm lumen Dr. Foster CTO with Jetstream G3™

15. Calcification

16. Calcification

17. After Pathway and 6 mm PTA

18. Thrombotic occlusion

19. After Pathway alone

20. After Pathway and PTA

21. Conclusions
Pathway device adds to the tool set for PAD intervention with the capability to address:
Calcification
Thrombus-containing lesions
ISR
Good stand alone results (PTA only) as demonstrated by low rates of stent usage
Evolutionary improvements have extended applications, safety and efficacy original device
New devices will address larger and smaller vascular needs

22. Procedural Outcomes 99% device success
Mean device activation time = 3:37 minutes
33% of procedures were stand-alone
57% used adjunctive balloon
Only 7% require adjunctive stent
Please include EBL or aspirate volume