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 | | NovaFlex+ Transfemoral System | |  | | | | | Control | | Flex catheter stabilizes balloon
shaft during deployment | | | Precision | | Balloon-expandable design allows
for user-controlled inflation and
precise delivery | | | Stability | | 360° Flex Tip provides tight balloon
shaft support during valve placement
and deployment | | | Edwards eSheath Expandable Introducer Sheath | | Combines a low profile with Dynamic Expansion Mechanism (DEM) | | | Designed to reduce vascular trama - Allows for transient sheath expansion during delivery
system passage - Reduces the time the access vessel is expanded
| | | | Allows for retrieval - DEM feature allows for valve retrieval†
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The Complete Edwards Transfemoral System
| Edwards SAPIEN XT Transcatheter Heart Valve | | Designed for predictable performance | | | NovaFlex+ Delivery System | | Predictable delivery, predictable results | | | Edwards eSheath Expandable Introducer Sheath | | Low profile combined with Dynamic Expansion
Mechanism to reduce vascular trauma | | | Product Name | 23 mm | 26 mm | 29 mm | | NovaFlex+ Transfemoral Kit | 9355NF23 | 9355NF26 | 9355NF29 | | Edwards SAPIEN XT Transcatheter Heart Valve | 9300TFX
(23 mm) | 9300TFX
(26 mm) | 9300TFX
(29 mm) | | NovaFlex+ Delivery System†† | 9355FS23 | 9355FS26 | 9355FS29 | | Edwards Expandable Introducer Sheath Set | 916ES23 | 918ES26 | 920ES29 | | RetroFlex Dilator Kit | 9100DKS | 9100DKS | 9100DKS | | Edwards Transfemoral Balloon Catheter | 9350BC20 | 9350BC23 | 9350BC25 | | Crimper | 9350CR | 9350CR | 9350CR | | Atrion QL2530 Inflation Device | 96402 | 96402 | - | | Atrion QL38 Locking Syringe Device | - | - | 96406 | †† Includes the Qualcrimp Crimping Accessory, 9300QC and 2-piece Crimp Stopper.
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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.
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