Edwards esheath ifu
WebFor SAPIEN 3™ & SAPIEN 3 Ultra™ transcatheter heart valves, Edwards™ COMMANDER™ delivery system, Edwards™ eSheath™ introducer set, Edwards™ … WebMar 25, 2015 · The current generation eSheath for the Edwards SAPIEN 3 TAVR is a nominal 14 F (~4.7 mm) or 16 F (~5.3 mm) femoral sheath with a dynamic expansion mechanism (DEM). This sheet system expands …
Edwards esheath ifu
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WebEdwards Crimper. Indications: The Edwards crimper is indicated for use in preparing the Edwards SAPIEN 3 Ultra transcatheter heart valve and the Edwards SAPIEN 3 transcatheter heart valve, for implantation. … WebGet in touch with us! For more information, submit a physician request form or call our Physician Referral line at 630-527-6363, Monday through Friday from 7 a.m. to 6 p.m. …
WebDevice Trade Name: Edwards SAPIEN 3 Transcatheter Heart Valve System . Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System . Device Procode: NPT . ... The Edwards eSheath Introducer Set (models 914ES and 916ES), as shown in Figure 6, consists of a hydrophilic coated, expandable sheath and 2 dilators. It is available in 14 … WebThe Edwards eSheath Introducer Set is supplied in a pouch and sterilized with ethylene oxide. 9.0 Storage The Edwards eSheath Introducer Set should be stored in a cool, dry place. 10.0 Device Disposal Used sheath sets may be handled and disposed of in the same manner as hospital waste and biohazardous materials. There are no special risks related
WebThe Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an ... WebEDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET INTRODUCER, CATHETER: Back to Search Results: Model Number 9610ES14: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888) Event Date 11/11/2024:
WebEdwards Lifesciences
WebEdwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Skip to main content. Patients & Care Partners. Heart Valve Disease Information Learn more about heart disease; Patient Resources sfc300400 switchWebThe Edwards eSheath introducer set must be used with a compatible 0.035” (0.89 mm) guidewire to prevent vessel injury. Precautions: Caution should be used in vessels that have diameters less than 5.5 mm or 6 mm as it may preclude safe placement of the 14F and 16F Edwards eSheath introducer set respectively. sfca032gh1ad4to-i-gs-226-stdWebThe device identification (di) numbers for edwards esheath introducer set are (b)(4). According to the instructions for use (ifu), cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral transcatheter aortic valve replacement ... sfca004gh3aa1to-i-ms-226-stdWeb3 2.0 Indications The Edwards SAPIEN XT Transcatheter Heart Valve, model 9300TFX, systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet … sf by the bayWebEDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET INTRODUCER, CATHETER: Back to Search Results: Model Number 9610ES14: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Hemorrhage/Bleeding (1888) Event Date 01/13/2024: theuerkauf\\u0027s tails pet servicesWebeSheath 188 ... IFU Code. Document languages. English, Swedish - Svenska, Danish - Dansk ... Mail a link to this document Download. Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System Edwards SAPIEN 3 and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve Edwards Commander Delivery System. IFU P/N. 10043259002A - MDD/MDR sfc 14-a hiltiWebedwards et al. 3671979: catheter mounted artificial heart valve for implanting in close proximity to a defective natural heart valve: 1972-06-27: moulopoulos: 3657744: method for fixing prosthetic implants in a living body: 1972-04-25: ersek: 3587115: prosthetic sutureless heart valves and implant tools therefor: 1971-06-28: shiley: 3548417 sfca16gbh2bv4to-c-qt-226-std