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Aupart MR, et al. Carpentier-Edwards pericardial valves in the mitral position: ten-year follow-up. J Thorac Cardiovasc Surg. 1997 Mar;113(3):492-8. (Freedom from structural …
· The Magna Ease model 3300TFX valve is a stented bovine. ... The results showed that major fatigue occurred for the Starr-Edwards 2320 at 150 million cycles, the Hufnagel trileaflet at 124 million ...
3300TFX-23mm: Edwards Carpentier-Edwards Perimount Magna Ease Pericardial Bioprosthesis - Aortic 23mm. Expired » Edwards » Heart Valves. Photos are for illustration purposes only and may not depict the exact item. Sign in to add this product to your favorites! Price: $989.00 per box of 1 In Stock: 0 box of 1: Status:
Model 3300TFX features the Carpentier-Edwards ThermaFix process, which confronts both major calcium binding sites: residual glutaraldehydes and phospholipids* General …
In Stock! Ships Today! $989.00 box of 1 - Edwards # 7300TFX-33mm - Edwards Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis: 33mm
· Device: Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis, Model 3300TFX: Generic Name: replacement heart-valve: Regulation Number
AccessGUDID - CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC (00690103176148)- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS. Skip to Main Content; ... Version or Model: 3300TFX Commercial Distribution Status: In Commercial Distribution Catalog …
It was reported that an edwards valve aortic valve model 3300tfx-23mm was explanted at implant due to 2+ aortic insufficiency (ai), then replaced with same model/size device with no further complications. Report indicates the surgeon had implanted a 3300tfx-23mm and when he came off pump, he had 2+ ai.
The Edwards Carpentier-Edwards PERIMOUNT Magna Ease aortic pericardial bioprosthesis model 3300TFX (also referred to as the Magna Ease aortic bioprosthesis) is a trileaflet bioprosthesis comprised of bovine pericardium that has been preserved in a
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Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement. All-Cause Mortality Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX Affected / at Risk (%) Total : 38/258 (14.73%)
ED MagnaEase Bro. 3 Pages. MagNa PerForMaNce MiTraleaSe. 4 Pages. VAMP Adult Brochure. 4 Pages. Thermodilution Catheter and IntroFlex Sheath with No Latex Components. 2 Pages. Advanced Technology Pulmonary Artery Catheter.
· Edwards Commander Delivery System (Figure 2) The Edwards Commander delivery system (usable length 105 cm) is used for delivery of the Edwards SAPIEN 3 transcatheter heart valve and consists of a Flex Catheter to aid in valve alignment to the balloon, tracking, and positioning of the THV. The delivery system includes a tapered tip …
Edwards lifesciences maintains an implant patient registry. This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry. Through the registry, edwards is notified when these devices are implanted.
Model 3300TFX features the Carpentier-Edwards ThermaFix process ‡, which confronts both major calcium binding sites: residual glutaraldehydes and phospholipids; General …
3300TFXCarpentier-Edwards ThermaFix ‡, : : 10 °C 25 °C (50-77 °F) : : 500ml()× …
Contact technical support. Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI …
· 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 requiring cardiopulmonary bypass. ... Model 3300TFX: Actual Study Start Date : October 2007: …
Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement. All-Cause Mortality …
Edwards received an inquiry for an echo review from the implanting surgeon regarding a patient with an implanted 3300tfx-21mm valve. Report indicates patient had bypass surgery approximately 5 years ago. ... Then, on (b)(6) 2011 had an avr and received a 3300tfx-23mm at first, however it was determined intra-operatively by the surgeon that a ...
EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE: Back to Search Results: Model Number 3300TFX: Device Problem Improper Flow or Infusion (2954) Patient Problem Aortic Regurgitation (1716) Event Date 08/04/2014:
AORTIC PERICARDIAL BIOPROSTHESIS: MODEL MAGNA EASE AORTIC 3300TFX, Product Code. 3300TFX21MM. Manufacturer of the medical device. EDWARDS LIFESCIENCES LLC. Category Name. HEART VALVES BIOLOGICAL TISSUE FROM ANIMAL WITH SUPPORT FOR SURGICAL SYSTEM. Category Code. P0703010102.
Of note, this pericardial aortic valve was initially used off label as it was implanted in the pulmonic position. Per the instructions for use (ifu), ¿the carpentier-edwards perimount magna ease pericardial bioprosthesis model 3300tfx is indicated for patients who require replacement of their native or prosthetic aortic valve.
AccessGUDID - CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC (00690103176162)- CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS. Skip to Main Content; ... Version or Model: 3300TFX Commercial Distribution Status: In Commercial Distribution Catalog …
· 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 purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients …
· Background The Carpentier-Edwards Perimount Magna mitral valve bioprosthesis (Edwards Lifesciences, Irvine, CA) is a low-profile version of the earlier Perimount valve that uses the ThermaFix process for enhanced calcium removal. The Magna valve has been in use since 2008, yet no publication, until now, has verified its …
History of Changes for Study: NCT01171625. Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX. A study version is represented by a row in the table. Select two study versions to compare. One each from columns A and B. Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study ...
Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC Version or Model: 3300TFX Commercial Distribution Status: In Commercial Distribution Catalog Number: 3300TFX27MM Company Name: Edwards Lifesciences LLC
Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC Version or Model: 3300TFX Commercial Distribution Status: In Commercial Distribution Catalog Number: 3300TFX19MM Company Name: Edwards Lifesciences LLC