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https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S037d.pdf
1 Edwards SAPIEN XT . Transcatheter Heart Valve wit h the NovaFlex+ Delivery System. Instructions for Use – Pulmonic . CAUTION: Federal (USA) law restricts these devices to …File Size: 771KB
https://academic.oup.com/ejcts/article/43/2/437/469050
Sep 26, 2012 · Rupture of the NovaFlex balloon (Edwards transfemoral balloon catheter) occurred during the inflation of the Edwards SAPIEN valve, resulting in dissection of the right common and external iliac arteries during withdrawal of the balloon catheter. The NovaFlex balloon is a part of the Edwards NovaFlex XT transfemoral delivery system.Author: Mehmet Gul, Hale Unal Aksu, Kursat Oz, Ihsan Bakir
http://kategorizacia.mzsr.sk/Pomocky/Download/RequestAttachment/3985
NovaFlex Transfemoral Delivery System Introducing the Edwards NovaFlex transfemoral delivery system, for easy, precise balloon-expandable delivery of the advanced Edwards SAPIEN XT transcatheter heart valve. This 18F delivery system offers controlled navigation, smooth crossing, and reliable placement.
https://www.edwards.com/ns20100302
The Edwards SAPIEN XT valve with the NovaFlex transfemoral delivery system is designed to provide easy, precise, balloon-expandable delivery of the valve. "The Edwards SAPIEN XT valve platform offers best-in-class valve performance with a low-profile delivery system," said Larry L. Wood, Edwards' corporate vice president, transcatheter valve ...
https://www.edwards.com/gb/devices/Heart-Valves/Transcatheter-Sapien-3
Now approved for aortic and mitral valve-in-valve procedures. The SAPIEN 3 valve is the only valve approved for valve-in-valve procedures in both the aortic and mitral positions, allowing patients at high or greater surgical risk to avoid an additional open heart procedure.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3528219/
It is reasonable to assume that the risk of vascular complications is reduced with the use of these lower-profile delivery systems. 5 The Novaflex transfemoral delivery system and eSheath (expandable-sheath technology developed specifically for the Edwards SAPIEN valve) is the latest generation.Author: Mehmet Gul, Ozgur Akgul, Mehmet Erturk, Abdurrahman Eksik, Aydin Yildirim
https://clinicaltrials.gov/ct2/show/NCT01113983
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery system and crimper accessories.
https://www.sciencedirect.com/science/article/pii/S1875213612000459
Initially, the transfemoral Retroflex system was utilized. However, the purpose-specific Ascendra delivery catheter was developed shortly afterwards. This has now been superseded by the Ascendra 2 system , which is lower profile, easier to de-air, can accommodate the SAPIEN-XT valve, and facilitates use by a …Author: John G. Webb, Ronald K. Binder
http://ht.edwards.com/scin/edwards/de/sitecollectionimages/products/transcathetervalves/tavitalk3.pdf
well as its NovaFlex transfemoral (TF) and Ascendra2 transapical (TA) delivery systems. These products resulted from extensive engineer-ing and testing, ensuring enhancements to both valve design and ease of use, without compromis-ing any of the hallmark features of the Cribier- …File Size: 2MB
https://www.biospace.com/article/releases/edwards-lifesciences-corporation-sapien-xt-transcatheter-valve-and-delivery-systems-receive-ce-mark-/
IRVINE, CA--(Marketwire - 03/02/10) - Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received CE Mark for its Edwards SAPIEN XT transcatheter aortic heart valve, as well as its NovaFlex transfemoral and Ascendra 2 transapical delivery systems.
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