DESIGNING THE FUTURE OF TAVI

Transcription

1 DESIGNING THE FUTURE OF TAVI

2 Meets the most critical needs in TAVI DESIGNED TO REDUCE PATIENT COMPLICATIONS Building on the proven benefits of the SAPIEN valve family, the SAPIEN 3 valve fulfills a promise to address the most pressing needs in transcatheter heart valve implantation. This achievement is a testament to Edwards undisputed leadership in TAVI and ongoing collaboration with implanting physicians. Outer skirt minimizes paravalvular (PV) leak Ultra-low delivery profile reduces vascular and bleeding complications MINIMIZE INTERVENTION AND UNNECESSARY MANEUVERS Reduced need for post-dilatation Predictable deployment and fine control of valve positioning Together, we re designing the future of TAVI. EXPAND TREATMENT POSSIBILITIES Valves sized to accommodate a broad range of patient anatomies 14F esheath accommodates smaller and challenging patient vasculature

3 A transformational achievement in valve engineering The SAPIEN 3 valve achieves an ultra-low 14F delivery profile EVEN WITH THE ADDITION OF AN OUTER SKIRT, AND WHILE RETAINING HIGH RADIAL STRENGTH FOR CIRCULARITY Designed to minimize PV leak Advanced frame design and geometry Edwards Commander Delivery System 14F esheath COMPATIBLE* WITH OPTIMAL POSITIONING CONTROL Dual articulation enables coaxiality even in challenging anatomies Fine control of valve positioning Low frame height respects the cardiac anatomy Edwards Certitude Delivery System 18F CERTITUDE SHEATH COMPATIBLE WITH SEAMLESS DEPLOYMENT Integrated pusher streamlines procedure Ergonomically designed handle for ease of use *14F esheath is compatible with 23 mm and 26 mm valves. 16F esheath is compatible with 29 mm valve. 18F Certitude sheath is compatible with 23 mm and 26 mm valves. 21F Certitude sheath is compatible with 29 mm valve.

4 Meets the to most critical Designed achieve the principles of aortic valve replacement needs in TAVI A transformational achievement ed wa r Ds c om m AnD er D el ivery system in valve engineering Edwards SAPIEN 3 Transcatheter Heart Valve ultra-low delivery profile with ed wa r D s c ertitu D e D el iv ery system optimal positioning control seamless deployment u lt ra- l ow D el iv ery pr of il e (14f esheath compatible)* Building on the proven inner AnD outer skirts benefits of the SAPIEN Polyethylene terephthalate (PET) inner and outer skirts Outer skirt is designed to minimize paravalvular (PV) leak valve family, the SAPIEN 3 valve fulfills a promise BoVine pericardial tissue to address the most pressing needs in transcatheter heart valve implantation. This achievement is a testament PREDICTABLE PROCEDURE LOW RATE OF to Edwards undisputed Balloon-expandable design ongoing collaboration withto Outer skirt designed minimize PV leak implanting physicians. Fine control of valve positioning COMPLICATIONS leadership in TAVI and High radial strength frame designed to promote full expansion Together, and apposition at the annulus we re designing the to minimize PV leak future of TAVI. Ultra-low delivery profile designed to reduce vascular and bleeding complications Low frame height for reduced conduction disturbances 18f 40% reduction in cross-sectional area 14f Optimal hemodynamics Proven long-term tissue durability* Leaflets optimized for hemodynamics and durability Carpentier-Edwards D u Al A rtic u lthermafix At i o n process is intended to reduce the f or c oa xia l i t yrisk of calcification durability *14F esheath is compatible with 23 mm and 26 mm Edwards SAPIEN 3 valves. 16F esheath is compatible with 29 mm Edwards SAPIEN 3 valve. Circularity at the annulus for uniform leaflet coaptation Circularity at the annulus promotes laminar flow Valves sized to accommodate a wide range of patient anatomies edwards sapien 3 Valve size transesophageal echocardiogram (tee) even in challenging anatomies native Annulus Area Edwards proven bovine pericardial tissue* Proprietary leaflet matching Area-Derived technology Diameter ecarpentier-edwards ArticulAtion integrated ultra-low c on tr f ThermaFix 23 mm mm mm2 f in mmo l oergonomically VAlV e po s idesigned tprocess i o n i n g feature anti-calcification pusher DeliVery 26 mm mm mm mm handle for ease of for streamlined profile 29 mm mm mm mm coaxial positioning for improved procedures 18F Edwards ease of use Certitude sheath compatible* t r u sted SH. Choice of prosthetic heart in adults: an update. J Am Coll Cardiol. 2010;55: B* Rahimtoola A l l oon - expa nd A valve Ble No clinical data are available with which to evaluate the long-term impact of the Carpentier-Edwards ThermaFix tissue process in D*18F esig n sheath Certitude is patients. compatible with 23 mm and 26 mm Edwards SAPIEN 3 valves. 21F Certitude sheath is compatible with 29 mm Edwards SAPIEN 3 valve. *Rahimtoola SH. Choice of prosthetic heart valve in adults: an update. J Am Coll Cardiol. 2010;55: Desig esig nin in gare th theewithfu fu tu retheof of tav i the Carpentier-Edwards ThermaFix tissue process in patients. No clinical data available which to evaluate long-term impact iof D n g tu re tav

5 DESIGNING THE FUTURE OF TAVI Meets the most critical needs in TAVI Designed to reduce patient complications, minimize intervention and unnecessary maneuvers, and expand treatment possibilities A transformational achievement in valve engineering Pioneering new features build on the proven strengths of the SAPIEN valve family Designed to achieve the principles of aortic valve replacement Provides a predictable procedure, low rate of complications, optimal hemodynamics, and durability For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Material for distribution only in countries with applicable health authority product registrations. Material not intended for distribution in USA or Japan. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Certitude, Edwards Commander, Edwards SAPIEN, Edwards SAPIEN 3, SAPIEN, SAPIEN 3, and ThermaFix are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. E4211/10-13/THV Edwards Lifesciences I edwards.com Route de l Etraz 70, 1260 I Nyon, Switzerland USA I Japan I China I Brazil I Australia I India