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https://www.accessdata.fda.gov/scripts/cdrh/Cfdocs/cfmaude/detail.cfm?mdrfoi__id=2414428
The retroflex 3 delivery system was returned to edwards for evaluation in a used condition. Visual and dimensional inspections were performed. Visual inspection revealed a longitudinal tear along the length of the balloon still attached to the catheter.
https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100041c.pdf
Iii Edwards SAPIEN Transcatheter Heart Valve with the RetroFlex 3 Edwards Delivery System Instructions for Use The following table identifies the bioprosthesis size that should be Caution: Federal (USA) law restricts this device used based on native valve annulus size, as measured by to sale by or on the order of a physician.
https://www.edwards.com/ns20080512
"The RetroFlex II delivery system is a big step forward. It is designed to give the physician maximum control when delivering and implanting the transcatheter aortic valve, making it easier to get to and then cross the patient's native valve," said Webb. Representatives from Edwards will be in the exhibition area at booth F02. The booth ...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4251339/
We report the case of an 85-year-old woman with severe aortic stenosis who underwent transcatheter aortic valve replacement with use of the Edwards S apien ® valve system. The procedure was complicated by rupture of the valve-deployment balloon, with separation and retention of the nose cone of the RetroFlex 3 ® delivery system in the iliac artery. Our endovascular retrieval of the equipment ...Author: Kelly D. Green, Alain Waked, Usman Majeed, Marat Fudim, Mark A. Robbins, Marshall Crenshaw, David Zh...
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.
http://mjr.barnabasheart.org/uploads/8/4/0/0/8400188/______199470004_ifu_110311.pdf
• RetroFlex 3 Delivery System – Model 9120FS23 for 23 mm valve procedure and 9120FS26 for 26 mm valve procedure (Figure 2) 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
https://www.ncbi.nlm.nih.gov/pubmed/25593532
Dec 01, 2014 · Percutaneous management of RetroFlex 3 balloon rupture and separation of the Edwards Sapien delivery system. Green KD, Waked A, Majeed U, Fudim M, Robbins MA, Crenshaw M, Zhao D. We report the case of an 85-year-old woman with severe aortic stenosis who underwent transcatheter aortic valve replacement with use of the Edwards Sapien(®) valve ...Author: Kelly D. Green, Alain Waked, Usman Majeed, Marat Fudim, Mark A. Robbins, Marshall Crenshaw, David Zh...
https://www.youtube.com/watch?v=Hmk2ro43FHM
Oct 17, 2012 · Edwards SAPIEN Transcatheter Heart Valve with the RetroFlex 3 Transfermoral System (TAVR) - Duration: 3:13. Saint Joseph Mercy Health System 54,772 viewsAuthor: HijaziMedical
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.sciencedirect.com/science/article/pii/S1875213612000459
The Edwards system evolved from a simple valvuloplasty balloon with a deflectable pusher RetroFlex™ catheter , to the RetroFlex 2 catheter that incorporated a tapered nosecone, then to the more refined RetroFlex 3 catheter . The nosecone greatly increased the ease of passage through the aortic arch and stenotic native valve.Author: John G. Webb, Ronald K. Binder
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