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CTO Crossing Devices CRT 2013 Raj Dave, MD, FACC, FSCAI Chairman, Division Of Cardiology Chief Medical Executive, Holy Spirit Cardiovascular Institute Holy Spirit Hospital Camp Hill, PA
Rajesh M. Dave, MD Honoraria: Abbott Laboratories, Atrium Medical Corporation, Cardiovascular Systems, Inc, Daiichi Sankyo, Bard Peripheral Vascular, Inc. , Pathway Medical Technologies, Inc. , Abiomed, Inc. and ev 3, Inc.
Disclosure • Physician Training: BARD, Spectranetics, Boston Scietific
The Debate of Crossing: SIA Vs Central • No randomized data to suggest one superior to other • Long Occlusions, Soft Occlusions and failed central crossing SIA is the best • Case for Central Luminal Cross: Adjunctive therapy options are expanded, No extension of treatment zone
Crossing Devices • Wire manipulations is an art and not universally present in every operator even after experience • CTO Crossing Devices increases the success rate amongst these operators, Shortens radiation time • CTO Crossing devices may increase the likelihood of central luminal crossing in certain cases
Crossing Devices: Options • • • Crosser Laser Ocelot Enabler P ( investigational) True Path
CROSSER 14 s Popliteal CTO Total Crossing Time – 42 Seconds
CROSSER 14 P Posterior Tibial CTO Total Crossing Time – 3 min 40 secs
True. Path™ CTO Device Rotating distal tip creates a micro-dissection through the occlusion • Designed to cross fibro-calcific CTOs • Diamond-coated distal tip rotates at 13, 000 rpm on a 0. 018” guidewire • Requires no capital equipment • Extension capability to 335 cm True. Path is a trademark of Boston Scientific.
True. Path™ CTO Wire Adjustable torquer 9 cm taper 130 cm hydrophilic coating 165 cm working length • . 018” Nitinol outer shaft tapers over distal 9 cm for optimized flexibility* • Compatible with ≥ 0. 018” support catheters with usable lengths of ≤ 135 cm *0. 0178” to 0. 0096”
True. Path™ Shaping Tool 15° bend • Shaping tool creates a 15°bend for added steerability
Enabler P Step 1: Anchor Manual inflation of the balloon to a low pressure of 1. 5 atm results in balloon anchoring against the vessel wall (between 4 mm-6 mm). The guidewire is centralized and free to move. Step 2: Activate The Pressure Control Unit (PCU) modulates the pressure within the balloon, increased pressure causes balloon elongation, such that the inner tube stretches and grips the guidewire and advances it. Decrease in balloon pressure results in the guidewire being released and free to move. Step 3: Cross Gently support the guidewire to advance. Luminal positioning is maintained by controlled guidewire advancement via the path of least resistance, allowing the use of atherectomy devices and drug eluting balloons. Proprietary and Confidential 20
The ENABLER System CE Approved ENABLER Balloon catheter • Catheter lumen: 0. 035” • Catheter length: 135 cm • Balloon length: 20 mm • Balloon Diameter: 6 mm • Guiding Sheath: 6 Fr Pressure Control Unit (PCU) • Disposable, battery operated Proprietary and Confidential 21
Prof Zeller - Herz-Zentrum, Bad Krozingen, Germany Occlusion length: 40 mm, Estimated occlusion age: > 12 m Contralateral approach, Calcification: Severe PCU activation duration: 8 min Proprietary and Confidential 22
Conclusion • CTO Crossing devices adds value to our CTO strategy by increasing success rate for a “Nonwire” Operator • Reduces Radiation and procedure time • Centrally Crossed lesion may expand therapeutic options with ? clinical benefit