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

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

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

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

Concept of LAST technique dissection and redirection within CTO segment

RCA CTO Refractory from Conventional Strategies

RCA CTO Refractory from Conventional Strategies

RCA CTO Refractory from Conventional Strategies

RCA CTO Refractory from Conventional Strategies

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

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

Bridgepoint Crossing and Reentry

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

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

FAST-CTOs Patient Demographics Vessels Treated and Refractory Category

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%

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; 72:771-780 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

Technical Success by Lesion Length

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

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: Choose View / Master / Slide Master from your menu. 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) 22

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: Choose View / Master / Slide Master from your menu. 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

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: Choose View / Master / Slide Master from your menu. 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

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: Choose View / Master / Slide Master from your menu. 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

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: Choose View / Master / Slide Master from your menu. 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

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

RCA CTO Primary Dissection Reentry Strategy for Efficiency

RCA CTO Primary Dissection Reentry Strategy for Efficiency

Initial and Final Antegrade Devices Facilitating Devices

Initial and Final Antegrade Devices Enabling Crossing Devices

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: www.whichmedicaldevice.com, www.sagepublications.com  

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