safety of st jude medical valves and


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St. Jude Medical One St. Jude Medical Drive

In nonclinical testing, St. Jude Medical heart valves and repair devices produced a temperature rise of less than or equal to 0.5C at a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of The St Jude Medical Trifecta aortic pericardial valve Background:The St Jude Medical Inc (St Paul, Minn) Trifecta valve is a novel aortic biological prosthesis that incorporates several design features, including a true supra-annular sewing cuff, a stent design that maximizes valve hemodynamics while minimizing leaflet stresses, and an ethanol-based anticalcification technology. This study establishes the safety and early clinical and St. Jude Medical Artifical Heart Valve National This is one of the early versions of the St. Jude Medical (SJM) artificial heart valve, a bi-leaflet valve made of pyrolytic carbon. There are four pivot points, and the edges of the donut are not as rounded as later models. A white Dacron sewing ring surrounds the Is the St. Jude Heart Valve MRI Safe? - ReferenceApr 10, 2020 · If a patient with a St. Jude heart valve needs an MRI, he should show the doctor his St. Jude Medical patient ID card, which contains information about safely DRAFT TRIFECTA INSTRUCTIONS FOR USEThe clinical investigation of the Trifecta Valve supports the safety of the Trifecta Valve. Between June 2007 and November 2009, one thousand and twenty-two (1022) subjects were implanted with the Trifecta Valve in the aortic Please contact your local St. Jude Medical representative. DIRECTIONS FOR USE Use either the TrifectaM Sizer set AccessGUDID - DEVICE:SJM Mechanical Heart Valve Apr 07, 2020 · Brand Name:SJM Mechanical Heart Valve Version or Model:A-101 Commercial Distribution Status:Not in Commercial Distribution Catalog Masters Mitral and Aortic Mechanical Valves AbbottThe valve holder/rotator is intended for single use only and should be discarded after surgery. The two retention sutures on the valve holder/rotator must be cut and removed before the SJM Masters Series Mechanical Heart Valve can be rotated. Do not pass catheters or other instruments through St. Jude Medical mechanical heart valves. Regent Aortic Mechanical Heart Valve AbbottThe valve holder/ rotator is intended for single use only and should be discarded after surgery. The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM Regent Mechanical Heart Valve can be rotated. Do not pass catheters or other instruments through St. Jude Medical mechanical heart valves. THE List - MRI SafetySt. Jude Medical, Mechanical Heart Valves Models include xxAGN-751, xxAGFN-756 xxAHPJ-505 or xxMHPJ-505 xxAEHPJ-505, xxAFHPJ-505 xxAJ-501 or xxMJ-501 Instructions for UseOptional handles may not be available in all locations. Please contact your local St. Jude Medical representative. Sizing the Valve . CAUTION:Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizers. Use only Model TF2000 sizers to size the valve. MRI-Ready Systems Manual - St. Jude Medical The St. Jude Medical MR Conditional system includes a St. Jude Medical MR Conditional device connected to one or more St. Jude Medical MR Conditional leads. For a list of the device/lead combinations that have been tested, see the device/lead combinations tables (page . 2). Testing has demonstrated that the St. Jude Medical MR Conditional INSTRUCTIONS FOR USEinappropriately small bioprosthesis may result in suboptimal hemodynamics. Use only the St. Jude Medical Bioprosthetic Heart Valve Sizer Set Model B 1000 with the Epic and Epic Supra valves. *Accelerated deterioration due to calcific degeneration of the Epic and Epic Supra valve may occur in:* children, adolescents, or young adults; St. Jude Medical HALO US IDE Trial Tests 15mm Heart Valves Feb 11, 2015 · The trial is essentially aimed at assessing the safety and efficiency of the St. Jude Medical Masters HPTM Series 15mm mechanical heart valve. According to St Jude Medical Regent valve - The Journal of Thoracic and Mar 01, 2006 · The initial Regent valve implanted in these 3 cases was likely oversized and the pivot guard not seated properly. In each case, the Regent valve was replaced with a valve of a smaller effective tissue annulus diameter (ETAD) compared with the St Jude Medical standard model and a smaller effective orifice area (EOA) determined from industry-provided data. Method for Removal of the St. Jude Valve - ScienceDirectFeb 01, 1988 · This method simplifies and increases the safety of this procedure. The St. Jude Medical valve is used widely for valve replacement. As with any prosthesis, mechanical failure may occur and thrombosis has been reported [l,21. The removal of a prosthetic valve that has been in place for a number of years is often difficult. St Jude Medical Epic porcine bioprosthesis:results of the Background:The St Jude Medical Epic heart valve (St Jude Medical, Inc, St Paul, Minn) is a tricomposite glutaraldehyde-preserved porcine bioprosthesis. The St Jude Medical Biocor porcine bioprosthesis is the precursor valve to the St Jude Medical Epic valve. The Epic valve is identical to the Biocor valve except that it is treated with Linx AC ethanol-based calcium mitigation therapy. Post-Approval Study Protocol of the St. Jude Medical Jan 20, 2012 · Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. THE List - MRI SafetySafety Info ID# Safety Topic / Subject Article Text 179:Heart Valves and Annuloplasty Rings:Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera St. Jude Medical St. Paul, M. 3.0:Conditional Management of Life-Threatening Bleeding in Patients With Jun 13, 2021 · Thromboembolic and bleeding complications following St. Jude Medical valve replacement:results of the German Experience With Low-Intensity Anticoagulation Study. Hering D, Piper C, Bergemann R, Hillenbach C, Dahm M, Huth C, Horstkotte D. Masters HP Valved Graft with Gelweave Valsalva St. Jude Medical prosthetic heart valves are indicated for use as replacement valves in patients with a diseased, damaged, or malfunctioning native or prosthetic valve. Possible side effects for all valvular implants include, but are not limited to:regurgitation, thromboembolic phenomena, resistance to flow, The St Jude Medical Trifecta aortic pericardial valve Mar 13, 2013 · The St Jude Medical Inc (St Paul, Minn) Trifecta valve is a novel aortic biological prosthesis that incorporates several design features, including a true supra-annular sewing cuff, a stent design that maximizes valve hemodynamics while minimizing leaflet stresses, and an ethanol-based anticalcification technology. This study establishes the safety and early clinical and hemodynamic AccessGUDID - DEVICE:Epic (05414734055604)AccessGUDID - Epic (05414734055604)- St. Jude Medical Porcine Mitral Bioprosthetic Heart Valve Trifecta St. Jude medical® aortic valve in pulmonary (c) choice of the most suitable valve;[3,3448] and (d)role of the surgical right ventricular remodelling. [4951] 2. Aims The purpose of this study is to assess the safety in terms of mortality and the early and mid-term out-comes of the use of the Trifecta St. Jude Medical® aortic valve used in the PV position for patients with PV St. Jude Medical Artificial Heart Valve National This is a St. Jude Medical (SJM) mechanical demonstration heart valve. It is a bi-leaflet valve with four pivots. The SJM valve was the first all carbon valve in clinical use. All St. Jude valves would be made with pyrolytic carbon, a material and coating recognized FDA expands approval of replacement heart valve, smallest The FDA granted approval of the Master Series Heart Valve to St. Jude Medical. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary Abbott Trifecta / Trifecta GT bioprosthetic aortic heart

  • ActionDevice DetailsProblem / BackgroundManufacturer ContactsDistributionEnquiriesRead Abbotts Technical Bulletin, dated 13 January 2020, on the Trifecta/Trifecta GT bioprosthetic surgical aortic heart valve (Appendix A in the PDF). 1. Note precautions regarding proper valve sizing and handling in accordance with the instructions for use (IFU):1.1. implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissue 1.2. do not oversize the valve 1.3. do not bend the titanium valve stent. The titaniuHemodynamics and early clinical performance of the St Dec 01, 2002 · The St. Jude Medical Regent mechanical aortic valve prosthesis represents a design modification of the existing St. Jude Medical bileaflet valves, with a modified external profile that results in a larger geometric orifice area without changing the existing design of the pivot mechanism or blood-contact surface areas. St. Jude Heart Valve Settlements Average Cave Value for The St. Jude Silzone mechanical heart valve implants manufactured by St. Jude Medical has been associated with dangerous medical side effects including heart failure, deep vein thrombosis, stroke, blood clots and pulmonary embolism. One of the most common questions clients ask our questions regarding their claim revolves around the potential settlement value attributed to their injuries Prosthetic heart valves:Evaluation of magnetic field Jul 31, 2000 · Additional concerns about the safety of heart valve prostheses and other implants relate to the potential heating of the implant. Temperature elevations during MRI procedures have been studied using ex vivo techniques for many different types of bioimplants, including heart valve prostheses ( 4 , 9 , 11 , 14 , 16 , 19 - 24 , 29 , 33 - 36 ). Aortic Valve Regent AbbottThe valve holder/ rotator is intended for single use only and should be discarded after surgery. The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM Masters Series Mechanical Heart Valve can be rotated. Do not pass catheters or other instruments through St. Jude Medical mechanical heart valves. On-X versus St Jude Medical Regent mechanical aortic valve Objective We aimed to compare the early haemodynamic data of the On-X and St Jude Medical (SJM) Regent bileaflet mechanical prostheses in the aortic position. Methods A retrospective study was performed using data collected prospectively for a national database. Thirty-three patients who had aortic On-X valve (On-X group) and 33 matched patients who had aortic SJM Regent valve (SJM group) FDA OK for St. Jude to Resume Portico TAVR TrialJun 04, 2015 · June 3, 2015 (updated June 4)-- Today St. Jude Medical announced FDA approval to resume their U.S. IDE trial for the Portico Transcatheter Aortic Valve System. The trial had been put on pause back in September 2014 due to safety concerns. Although the company did not issue a press release at that time about the interruption, they did respond to a question, posed by Shelley Wood of

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