Intraluminal Coronary Reentry Bridgepoint Medical CTO Crossing Systems

Intraluminal Coronary Reentry Bridgepoint Medical CTO Crossing Systems Craig A. Thompson, M. D. , MMSc. Director, Invasive Cardiology and Vascular Medicine Yale University School of Medicine New Haven, CT USA

DISCLOSURES Craig A. Thompson, MD Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Abbott Vascular, Boston Scientific, Cordis Consulting Fees/Honoraria Abbott Vascular , Bridgepoint Medical, Medtronic, Sanofi-Aventis Major Stock Shareholder/Equity None Royalty Income None Ownership/Founder None Intellectual Property Rights None Other Financial Benefit None

Acknowledgements William L Lombardi, M. D. (Co-PI) St. Joseph Hospital, Bellingham WA, USA Mario Araya, M. D. Christian Dauvergne, M. D Instituto Nacional del Tơrax, Santiago, Chile Humberto Torres, M. D. Mauricio Anina, M. D. Hospital Gustavo Fricke, Viña del Mar, Chile Arnoldo Aguirre, M. D. Ruben Lamich, M. D. Hospital Barros Luco Truddeau, Santiago, Chile Patrick Whitlow, M. D. (PI) Cleveland Clinic Foundation, Cleveland, OH, USA M. Nicholas Burke, M. D. Minneapolis Heart Institute Foundation, Minneapolis, MN USA R. Michael Wyman, M. D. Torrance Memorial Medical Center, Los Angeles, CA USA Etsuo Tsuchikane, M. D. Toyohashi Heart Center, Toyohashi, Aiichi, Japan Jeffery Moses, M. D. New York Presbyterian Hospital, Columbia University, New York, NY USA Bridgepoint Medical Minneapolis, MN, USA Eduardo Cebasas CAMIR Ltd. , Viña del Mar, Chile

Bridgepoint Medical Systems Crossboss™ technique • Support catheter ¡ ¡ Highly torqueable coiled-wire shaft 0. 014 wire compatible • Spinning displaces friction and promotes forward movement • Can redirect with wire • Atraumatic tip rarely exits vessel • True lumen or subadventitial CTO crossing

Bridgepoint Medical Systems Stingray™ and Stingray GW technique • Flat balloon ¡ Self orientation • 3 wire ports ¡ OTW port ¡ Adventitial port ¡ Lumen port

Bridgepoint Medical Systems Stingray™ and Stingray GW technique • Wire probe ¡ Find lumen access port • Stingray Guidewire ¡ Distal fiber allows wire to “grip” tissue ¡ Facilitates reentry

Bridgepoint Medical Devices technique

Bridge. Point FIM Data • • 41 patients with de novo CTO Centers 2. Instituto Nacional del Tórax, Santiago, Chile Hospital Gustavo Fricke, Viña del Mar, Chile 3. Hospital Barros Luco Truddeau, Santiago, Chile 1. • Primary Efficacy Endpoint: ability to place a guidewire into the true lumen distal to the CTO • Primary Safety Endpoint: In-hospital MACE

Bridge. Point FIM • • • 76% male 47% diabetic Average length of 23. 3 mm 37% RCA 37% LAD 27% LCX Technical Success: 36/41 (87. 8%) In-hospital MACE: 0/42. 30 Day MACE: 0/13 (13 patients followed for 30 days to date)

The Bridgepoint FIM Chilean Experience --- early lessons • Safe and feasible as intended • The system is versatile ¡ Several tools to complement technique, rather than supplant technique • The Crossboss, Stingray balloon, and Stingray guidewire can be used alone and in combination • Device iteration Wire-balloon compatibility ¡ Crossboss torquing --- stress relief ¡

The Bridgepoint FIM Chilean Experience --- early lessons 2 • Lesion length is less relevant • Crossboss is good with Calcium, but not great ¡ May need aggressive wire manipulation to push dissection forward • Distal target and visualization is most important

Lesson- Crossboss can pass true lumen to true lumen in straight segments

Lesson – lesion length less important, distal target very important

Limited Subadventitial Tracking and Reentry (LAST)

Lesson – lesion length, sidebranch access, reposition balloon to good target

The value of the distal target for reentry Longitudinal Cross Section

Chilean FIM Experience Crossboss™ lessons Can cross straight CTOs true lumen to true lumen often ¡ Will predictably go subadventitial on curves ¡ May need to be redirected with conventional guidewires at shallow angle sidebranches ¡ Good with calcium, but not great ¡ • May need additional stiffwire or knuckle wire Spin fast ¡ Minimal forward pressure…let device do the work ¡ Leaves smooth channel…very easy to rewire if needed ¡ Tracks tortuosity very well ¡ Stores torque…stop spinning and let slow to a stop ¡

Chilean FIM Experience Stingray™ and Stingray Guidewire lessons ¡ Prep with large syringe to improve visualization ¡ Works best with large target • Reposition if necessary ¡ Works best in segments with good contrast filling ¡ Guidewire reentry should occur in proximity to Stingray balloon (0 -15 mm) ¡ Stingray GW is very effective of lumen reentry ¡ Stingray GW is not effective for CTO lesion wiring over long distance

Bridgepoint Medical Devices for CTO conclusions • • Complement, rather than supplant, technique Devices used alone or in combination Good for primary CTO therapy Good for recovery of “failing” cases (e. g. dissection/false channel) • Fast • Successful ¡ CTO length, tortuosity less relevant • Safe