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https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100041c.pdf
The RetroFlex 3 Delivery System is indicated for the failure. Measure the patient's creatinine level prior The Dlivey etr~lex3 Sste is ndiatedfortheto the procedure. Contrast media usage should be.-transfemoral delivery of the Edwards SAPIEN monitored. Transcatheter Heart Valve. * Patient injury could occur if the delivery system is
https://www.annalsthoracicsurgery.org/article/S0003-4975(13)02836-1/fulltext
We describe our experience using the Edwards Sapien transfemoral Retroflex 3 catheter delivery system for transcatheter aortic valve replacement through the transapical and transaortic approaches. Transthoracic transcatheter valve replacement by the transapical and transaortic approaches can be safely and effectively performed with the Retroflex 3 delivery catheter, which affords several ...Author: Isaac George, Jacob Kriegel, Tamim Nazif, Bindu Kalesan, Jean-Michel Paradis, Omar Khalique, Rebecca...
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.youtube.com/watch?v=Hmk2ro43FHM
Oct 17, 2012 · Edwards Sapien Transcatheter Heart Valve With The RetroFlex 3 transfemoral System ... Edwards Sapien Transcatheter Heart Valve with RetroFlex 3 ... Transapical Delivery System ...Author: HijaziMedical
http://mjr.barnabasheart.org/uploads/8/4/0/0/8400188/______199470004_ifu_110311.pdf
The RetroFlex 3 delivery system includes a rotating wheel within the handle for articulation of flex catheter, a tapered tip at the distal end of the delivery system to facilitate crossing the native valve, a balloon for deployment of the bioprosthesis, and radiopaque markers as indicated in Figure 2. Black dots indicate position of radiopaque ...
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2973178
The retroflex 3 delivery system was returned to edwards for evaluation. Visual and dimensional inspections were performed. Visual inspection revealed a small tear on the balloon wall located just proximal of the distal nose cone which appeared to be due to mechanical damage.
https://www.biospace.com/article/releases/edwards-lifesciences-corporation-receives-ce-mark-for-new-transfemoral-transcatheter-valve-delivery-system-/
Feb 11, 2009 · ST-PREX, SWITZERLAND--(Marketwire - February 11, 2009) - Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced today that it received CE Mark approval for European commercial sales of the new RetroFlex 3 transfemoral delivery system for the Edwards SAPIEN transcatheter heart valve. The RetroFlex 3 delivery system is …
https://www.medlatest.com/companies/edwards-lifesciences-receives-ce-mark-for-new-transfemoral-transcatheter-valve-delivery-system/
Edwards Lifesciences Corporation, the world leader in the science of heart valves, announced today that it received CE Mark approval for European commercial sales of the new RetroFlex 3 transfemoral delivery system for the Edwards SAPIEN transcatheter heart valve.
https://www.youtube.com/watch?v=yVrPVjtrhK4
Mar 22, 2013 · Instead of traditional open heart surgery, a collapsible aortic heart valve is placed via the femoral artery in the thigh using the Retroflex 3 transfemoral delivery system.Author: McLaren Northern Michigan
https://www.sciencedirect.com/science/article/pii/S0003497513028361
Transthoracic Access for Transcatheter Aortic Valve Replacement: Technique Using the Edwards Sapien Retroflex Delivery System. ... We describe our experience using the Edwards Sapien transfemoral Retroflex 3 catheter delivery system for transcatheter aortic valve replacement through the transapical and transaortic approaches. Transthoracic ...Author: Isaac George, Jacob Kriegel, Tamim Nazif, Bindu Kalesan, Jean-Michel Paradis, Omar Khalique, Rebecca...
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