1. Intraluminal Coronary Reentry Bridgepoint Medical Crossboss and Stingray Systems
Craig A. Thompson, M.D., MMSc.
Director, Cardiovascular Catheterization and Intervention
Yale University School of Medicine/Yale New Haven Hospital
Consultant (Hon) Heart Hospital, London and London Chest Hospital

2. Craig A. Thompson, MD Consulting Fees: Abbott Vascular
Terumo Cardiovascular Systems Group
Ownership Interest (Stocks, Stock Options, or other Ownership Interest):
Bridgepoint

3. Antegrade Dissection Reentry Techniques
Lumen
CTO
Distal cap
random
STAR reentry
CTO
Distal cap
Lumen
LAST redirection
CTO
Distal cap
Lumen
Bridgepoint reentry

4. Why Develop Limited Subadventitial Tracking (LaST)?
Bailout for complex cases
Of cases viewed by highly experienced operators as suitable for retrograde, ~20% of time collaterals cannot be crossed
Bailout for failed connection after successful retrograde collateral crossing
Treatment option for patients not suitable for retrograde at all and refractory to conventional approach
Preceded availability of dedicated reentry tools

5. Concept of LAST technique dissection and redirection within CTO segment

6. RCA CTO Refractory from Conventional Strategies

7. RCA CTO Refractory from Conventional Strategies

8. RCA CTO Refractory from Conventional Strategies

9. RCA CTO Refractory from Conventional Strategies

10. The CrossBoss™ CTO Catheter
CrossBoss is designed to quickly and safely deliver a guidewire via true lumen or subintimal pathways
Multi-wire coiled shaft
Tracks via FAST Spin Technique
Highly torqueable coiled-wire shaft
FAST Spin reduces push required to cross CTO
Atraumatic distal tip advanced across a CTO ahead of the guidewire
OTW 0.014” guidewire compatible

11. The Stingray™ CTO Re-Entry System
Stingray System (catheter and guidewire) is designed to accurately target and re-enter the true lumen from a subintimal position
Unique self-orienting balloon has a flat shape for true lumen targeting
180° opposed and offset exit ports for selective guidewire re-entry
Re-entry probe at Stingray Guidewire tip

12. Bridgepoint Crossing and Reentry

13. FAST-CTOs Overview
FAST-CTOs: Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Objective: demonstrate safety and effectiveness of BridgePoint Medical CTO System compared to historical controls
BridgePoint Medical CTO System
CrossBoss CTO Catheter
Stingray CTO Re-Entry System
Stingray CTO Orienting Balloon Catheter
Stingray CTO Re-Entry Guidewire

14. FAST-CTOs Study Design
149 Patients, 20 Centers
Multicenter, non-randomized, IDE study
Historically-controlled
Control literature consisted of similarly designed CTO device trials with similar technical success and safety measures

15. FAST-CTOs Patient Demographics Vessels Treated and Refractory Category

16. FAST-CTOs CTO Characteristics
Vessel
Measure
FAST-CTOs1
(n=147)
Crosser
(n=125)
JCTO
Registry
(n=498)
NHLBI Registry1,2
(n=64)
Baseline RVD
2.9 ± 0.4
2.9 ± 0.6
2.9 ± 0.7
CTO Length
(Range)
32 ± 20
(3-100)
23 ± 13
(-)
14 ± 13
22 ± 14
Calcification
34%
65%
55%
28%
Tortuosity
41% 3% -
30%
>45˚ Angulation
25%
31%
45%
Side Branches
33%
66%
79%
Bridging Collaterals
37%
43%
22%

17. FAST-CTOs Compared to Other CTO IDE Studies
Endpoint
FAST-CTOs
Crosser1
SafeCross2
Frontrunner3
# of Patients
147
125
116
107
Tech Success
77%
61%
54%
56%
30-Day MACE
4.8%
8.8%
6.9% 8%
CTO Length (Range)
31.6
(3-100)
23.4 (≤305)
27.14
(6-80)
21.5
(≤255)
1 Tiroch, et al, Catheter Cardiovasc Interv 2008; 72:
2 Baim, et al, Am J Cardiol 2004;94:853–858
3Whitlow, et al, J Am Coll Cardiol 2002;39:29A [Abstract]
4 Reported as “narrowing length”
5 Protocol exclusion criterion

18. Technical Success by Lesion Length

19. FAST-CTOs Results Procedure/Fluoroscopy Time
Measure
FAST-
CTOs
(n=147)
min
Historical
Control
(n=661)
JCTO
Registry
(n=498)
Crosser
(n=125)
Proc Time
Mean ± SD
Median (Range)
105 ± 54
96 (17-332)
146 -
108
Fluoro Time
44 ± 25
41 (5-163) 53
45 (1-301) 44

22. RCA CTO complex This is the Bulleted List slide.
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23. RCA CTO complex This is the Bulleted List slide.
To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left)
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Select the text at the bottom of the slide and type in a short version of your presentation title.
Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) 23

24. RCA CTO complex This is the Bulleted List slide.
To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left)
The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide.
If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page.
Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows:
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Select the text at the bottom of the slide and type in a short version of your presentation title.
Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) 24

25. RCA CTO complex This is the Bulleted List slide.
To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left)
The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide.
If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page.
Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows:
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Select the text at the bottom of the slide and type in a short version of your presentation title.
Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) 25

26. RCA CTO complex This is the Bulleted List slide.
To create this particular slide, click the NEW SLIDE button on your toolbar and choose the BULLETED LIST format. (Top row, second from left)
The Sub-Heading and footnote will not appear when you insert a new slide. If you need either one, copy and paste it from the sample slide.
If you choose not to use a Sub-Heading, let us know when you hand in your presentation for clean-up and we’ll adjust where the bullets begin on your master page.
Also, be sure to insert the presentation title onto the BULLETED LIST MASTER as follows:
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Select the text at the bottom of the slide and type in a short version of your presentation title.
Click the SLIDE VIEW button in the lower left hand part of your screen to return to the slide show. (Small white rectangle) 26

27. Overall Strategy Initial planning Antegrade Wire Escalation
Lesion Length>20mm
Poor Distal Target,
Good Collaterals
Or Ambiguous Proximal cap
Retrograde
Antegrade Wire Escalation
Reentry
Lesion Length<20mm
Poor distal Target
Poor Collaterals
Dissection-Reentry
LaST
Lesion Length <20mm,
Good Distal Target
Good Collaterals
Antegrade Wire Escalation
Dissection Reentry
Retrograde
LaST
Lesion Length > 20mm
Dissection-Reentry
Antegrade wire escalation/LaST

28. RCA CTO Primary Dissection Reentry Strategy for Efficiency

29. RCA CTO Primary Dissection Reentry Strategy for Efficiency

30. Initial and Final Antegrade Devices
Facilitating Devices

31. Initial and Final Antegrade Devices
Enabling Crossing Devices

32. Crossboss CTO Catheter, Sapien, Watchman Among Picks for Best Cardiac Devices of 2011
January 25, 2012 — Which Medical Device announced the winner of its Device of the Year Award 2011 in the cardiology category. The expert panel of judges reviewed the nominations for the most significant, innovative and invaluable devices, and the winner and runners-up in the cardiology category are:
Winner
The winner of the cardiology category is the CrossBoss CTO Catheter manufactured by BridgePoint Medical. Which Medical Device Senior Editor for Cardiology Azfar Zaman commends this novel piece of technology with a good success rate in opening chronic occlusions, saying, “It is a quantum leap in the world of CTOs.”
Runner-up
The judges chose both the SAPIEN Transcatheter Heart Valve from Edwards Life Sciences and Medtronic’s Corevalve. The panel commented that, “Both these devices have stood the test of time and the medium term (five years) performance of both valves is sufficiently robust to hope that TAVI may well become the first preferred option in patients with aortic stenosis.”
Special commendations
Special mention is given to the Watchman device from Boston Scientific, which has the potential to improve lives by stopping the need for warfarin in patients with atrial fibrillation.
The judging panel also praised the Absorb Bioresorbable Vascular Scaffold from Abbott Vascular, saying  “We believe that this is the next generation for stents; it promises much but needs to deliver.”
For more information:

33. FAST-CTOs Conclusions
The BridgePoint Medical CTO System is safe and effective in the treatment of coronary epicardial chronic total occlusions
Procedure time with the System is shorter with lower fluoroscopy times compared to historical controls
The Bridgepoint Medical CTO system’s effectiveness, safety, and efficiency compares favorably with other investigated devices and techniques for therapy of CTO