edwards lifesciences model 3300tfx mri safety

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The INSPIRIS RESILIA Aortic Valve, Model 11500A is similar in design to the Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis, Model 3300TFX. Adverse events associated with the use of Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesmpiled from the literature

tissue (Edwards Lifesciences LLC, Irvine, CA, USA) has been . ... Aortic Valve (Model 3300TFX), except for the tissue technol - ogy of the leaflet material. The Model 11000A incorporates ... MRI or CT scan confirmed stroke, cerebrovascular accident, or transient ischaemic attack …

May 27, 2020· Hemophilia 22. Patients who are using Methotrexate at doses of 15mg or more per week 23. Patients who have unsuitable condition to undergo Brain MRI(Magnetic resonance imaging) and/or Cardiac CT(computed tomography) (e.g., tremor from Parkinson's disease). This is …

Sep 2002 - Nov 20023 months. * Assisted in the creation of a marketing strategy to promote Napa Brand auto supplies to Mexico. * Created advertising pamphlets which increased sales by over 10% for ...

Jul 28, 2010· Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX 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.

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Safety Topic / Subject ECHELON (45 and 60) ENDOPATH Linear Cutter Staplers, staple ECR60G, ECR60W, ECR60B, ECR60D, ECR45W, ECR45B, ECR45D, ECR45G, ECR45M ... Model 4900 Edwards Lifesciences LLC 1.5,3: …

Edwards M-B, Draper ERC, Hand JW, et al. Mechanical testing of human cardiac tissue: some implications for MRI safety. J Cardiovasc Magn Reson 2005;7:835-840. Edwards M-B, Ordidge RJ, Thomas DL, et al. Translational and rotational forces on heart valve prostheses subjected ex vivo to a 4.7 T MR system. J Magn Reson Imaging 2002; 16:653 –659.

Aug 04, 2017· Edwards Lifesciences LLC One Edwards Way Irvine, CA USA 92614 Phone: 949.250.2500 Fax: 949.250.2525 COMMENCE-P Trial COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement (COMMENCE-P) NCT02656290 August 4, 2017

Model 4600, heart valve. Baxter Healthcare Corporation Santa Ana, CA. 1.5. Safe More... Heart Valves and Annuloplasty Rings More... Carpentier-Edwards aortic and mitral bioprostheses. Models 2625, 6625. Edwards Lifesciences LLC.

Jun 14, 2018· If you need a new heart valve, the replacement may be mechanical or biological. Which is best depends on your age and other factors, but your preferences will also figure in. Find out what you ...

IFUs and Operator Manuals are subject to change; the most current version is available on this site. If you do not find the document you need, have difficulty accessing the document, or would like to request a printed copy (at no charge), please contact Edwards Support at 1-888-570-4016 or at [email protected].

May 27, 2020· Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX Brief Summary The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures ...

The Edwards SAPIEN 3 THV (model 9600TFX, 20, 23, 26, and 29 mm), as shown in Figure 1, is comprised of a balloon-expandable, radiopaque, cobalt-chromium (MP35N) frame, a trileaflet bovine pericardial tissue valve, a polyethylene terephthalate (PET) internal fabric

4. Edwards Lifesciences Corporation, Carpentier-Edwards Magna Ease Pericardial Aortic Bioprosthesis Model 3300TFX, Instructions for Use, 2009. Echo follow-up at one year. 5. CarboMedics, Inc., A Sorin Group Company. Mitroflow Aortic Pericardial Heart Valve, Pre-Market Approval Application Summary of Safety and Effectiveness Data, P060038, 2007.

Carpentier-Edwards Magna II Pericardial Aortic Heart Valve Prosthesis Model 3300/3300TFX Elgiloy alloy Edwards Lifesciences Irvine, CA. Strength 3. Object Status Conditional 5. Safety Topic / Subject Heart Valves and Annuloplasty Rings. Object Category Heart Valves and Annuloplasty Rings.

pericardial aortic bioprostheses Edwards Lifesciences LLC. 1.5,3. Conditional 5 More... Heart Valves and Annuloplasty Rings More... Carpentier-Edwards Physio II mitral annuloplasty ring. Model 5200. Edwards Lifesciences LLC.

Global Unique Device ID: 00690103163643. Version (Model) Number: 3000TFX. Device Name: . Company Name: Edwards Lifesciences LLC. Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC.

Oct 07, 2021· Edwards Lifesciences does not review past postings to determine whether they remain accurate, and information contained in such postings may have been superseded. We do not accept responsibility and specifically disclaim any liability for readers' use of information contained in any archived document.

Carpentier-Edwards PERIMOUNT Magna Ease pericardial aortic bioprosthesis Model 3300TFX Features Lower profile Ease of implant Supra-annular design Upsize potential Bioengineered Flexible CoCr alloy stent Pericardial leaflets ThermaFix process Magna Ease valve Carpentier-Edwards PERIMOUNT Magna Ease aortic heart valve Specifications Indications The Carpentier-Edwards …

Model 3300TFX features the Carpentier-Edwards ThermaFix process ... Important safety information . Important safety information . ... Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

Edwards Lifesciences is driven by a passion to help patients. Updates on Diversity, Inclusion & Belonging at Edwards. Messages from our leadership. Patients. We are dedicated to improving the lives of patients fighting cardiovascular disease and critical …

Edwards Lifesciences LLC One Edwards Way Irvine, CA USA 92614 Phone: 949.250.2500 Fax: 949.250.2525 Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX NCT01171625 September 15, 2009

Nov 01, 2012· Only patients who received a stented Carpentier-Edwards xenopericardial tissue valve (model 3000TFX and 3300TFX, Edwards Lifesciences, Irvine, Calif) were selected. The control group included patients who received mechanical bi-leaflet aortic valve replacement (St Jude Medical, Minneapolis, MI, or ATS Medical, Plymouth, MI) during the same period.

Dec 19, 2017· In the COMMENCE trial [17,20], 679 patients underwent Carpentier-Edwards PERIMOUNT Magna Ease™ aortic valve replacement with RESILIA™ tissue (Model 11000A) and similar excellent safety and ...

Technischer Kundendienst. Kontaktieren Sie den technischen Kundendienst von Edwards Lifesciences unter der 800-822-9837 (USA) oder der 949-250-2500 für zusätzliche Informationen zur MRT-Sicherheit unserer Produkte. Oder wenden Sie sich online an den technischen Kundendienst. Geben Sie bei Ihrer Anfrage ggf. die Modellnummer des Implantats an.

The Edwards SAPIEN 3 Transcatheter Heart Valve (THV), model 9600TFX, and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at high or

procedures in patients who have been implanted with Edwards Lifesciences (formerly Baxter Healthcare ... for patients undergoing magnetic resonance imaging (MRI) procedures using MR systems operating ... (Stented Tissue) Model Reference Carpentier-Edwards PERIMOUNT Magna Ease pericardial aortic bioprosthesis 3300TFX 20, 21, 22 :

Carpentier-Edwards PERIMOUNT Theon mitral pericardial bioprosthesis 6900PTFX 1 Carpentier-Edwards bioprosthetic valved conduit 4300 1 Testing of these devices in a magnetic field of 1.5, 3.0, and 8.0 tesla has shown that these devices are safe and compatible during MRI (magnetic resonance imaging) procedures.