Retroflex 3 Delivery System

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MAUDE Adverse Event Report: EDWARDS LIFESCIENCES …

    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.

Iii Transcatheter Heart Valve with the RetroFlex 3 Edwards ...

    https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100041c.pdf
    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. transesophageal echocardiography (TEE).

Percutaneous Management of RetroFlex 3 Balloon Rupture and ...

    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...

Reverse Angle Doctor Blade Systems (RADBS) - Retroflex

    http://www.retroflex.com/reverse-angle-doctor-blade-systems-radbs/
    Retroflex engineers and builds the Reverse Angle Doctor Blade System (RADBS) with superior features that deliver consistent performance without constant adjustments or maintenance. Through years of on-press testing, the Retroflex RADBS has become one of the most respected doctor blade systems on the market today when replacing older systems or ...

Edwards SAPIEN Transcatheter Heart Valve with the ...

    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 ...

SAPIEN 3 transcatheter heart valve Edwards Lifesciences

    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.

Percutaneous Management of RetroFlex 3 Balloon Rupture and ...

    https://thij.org/doi/abs/10.14503/THIJ-13-3447
    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 system. The procedure was complicat...Author: Kelly D. Green, Alain Waked, Usman Majeed, Marat Fudim, Mark A. Robbins, Marshall Crenshaw, David Zh...

Percutaneous management of RetroFlex 3 balloon rupture and ...

    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...

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