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A, 25-mm valve under normal aortic testing conditions (120/80 mm Hg). B, 25-mm valve under normal pulmonary testing position (28/11 mm Hg). C, 25-mm valve under pulmonary hypotension testing conditions (15/5 mm Hg). 2021-02-05 · accessgudid - carpentier-edwards perimount magna ease pericardial bioprosthesis - aortic (00690103176148)- carpentier-edwards perimount magna ease pericardial aortic bioprosthesis The Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat aortic valve replacement for structural valve failure compared with the Perimount Magna Ease bioprosthesis. Further comparative studies with echocardiographic data on structural valve deterioration and longer follow-up are needed to confirm these findings. The Perimount Magna Ease aortic valve (PMEAV) represents an attractive device in such cases. We examined the early hemodynamic performance, the mid-term outcomes of the PMEAV, and the impact of Methods: A total of 346 consecutive patients with aortic valve disease underwent aortic valve replacement between January 2003 and November 2011, with implantation of the Trifecta (group 1, n ¼ 121), the Perimount-Magna (group 2, n ¼ 126), or the Magna Ease bioprosthesis (group 3, n ¼ 99). Clinical and Magna Ease sizes 19mm, 25mm, and 29mm Pressure drop testing for Model 11000A test valves show no statistically significant differences from the Carpentier-Edwards PERIMOUNT Magna Ease reference valves that previously demonstrated correlation with the Bernoulli relationship. These data justify using a Bernoulli coefficient of four with Model 11000A.

® PERIMOUNT® Magna Ease™, Model 3300TFX. Study Design: This is a prospective, single-arm, multi-center study to be conducted in the US, and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. Study Background Approximately 250,000 heart valve operations are performed annually worldwide.

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The PERIMOUNT Magna Ease Aortic Valve A first in design, with a history of demonstrated performance. Descended from a proven family of PERIMOUNT surgical valves, the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve is the first biomechanically engineered valve designed specifically for the aortic position. Find out all of the information about the Edwards Lifesciences product: aortic valve bioprosthesis PERIMOUNT Magna Ease. Contact a supplier or the parent company directly to get a quote or to find out a price or your closest point of sale.

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Background: Approximately 250,000 heart valve operations are performed annually worldwide. An intensive research and development effort has led to progressively more advanced heart valve prostheses. The Carpentier-Edwards Perimount Magna Ease (CEPME) prosthesis represents the latest iteration of the Edwards Perimount series of aortic tissue valves. At 7-year, the Trifecta cohort had significantly higher risk of repeat aortic valve replacement for structural valve failure (3.3% vs. 0%), repeat aortic valve replacement for any cause (3.6% vs. 0.4%) and repeat aortic valve replacement and/or prosthetic valve endocarditis (4.1% vs.

A, Freedom from valve failure in patients with Magna/Magna Ease and Mitroflow LXA valves in the aortic position. B, Serial echocardiographic assessment of maximum instantaneous gradient across the bioprosthetic aortic valve over time for the Magna/Magna Ease and Mitroflow LXA valves. 2020-09-01 · The Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat aortic 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: Sign repertoire: Registered: Group of similar Medical devices: 70048 Methods: This is a comparative analysis of the outcome of the Trifecta (Abbott, Abbott Park, IL) and Perimount Magna Ease (Edwards, Lifesciences Corp, Irvine, CA) bioprostheses from the FinnValve registry, a Finnish nationwide database including patients with aortic stenosis who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis between 2008 and 2017. The aortic valve was sized and a 21 mm Carpentier–Edwards PERIMOUNT Magna Ease valve was selected for aortic valve implantation. The valve was implanted in an intra-annular location using interrupted, nonpledgeted 2–0 Ticron suture (M/s Covidien Domingo, Dominican Republic, USA) ( Figs. 1A–H).
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Nilsson, Roy Larsen, Kari Borch, Sophie Fosså, Lisa Baltesgard, Magna. 3 3f Enable Aortic Bioprosthesis (model 6000) (23 November 2014).

Perimount Magna EOAI chart with postoperative echo-cardiographic data and found that the sensitivity of the Perimount chart for predicting postoperative PPM was only 35%, with a negative predictive valve of only 53%. We created an EOAI valve chart comparing four popular stented aortic bioprostheses utilizing their manufactur- 2010-06-28 · Normal Doppler echocardiographic values of aortic valve prosthesis; Valve Size n Peak gradient (mm Hg) Mean gradient (mm Hg) Peak velocity (m/s) Effective orifice area (cm 2) ATS open pivot AP ATS open pivot (bileaflet) 16 6 47.7 ± 12 27 ± 7.3 3.44 ± 0.47 0.61 ± 0.09 19 9 47 ± 12.6 26.2 ± 7.9 3.41 ± 0.43 0.96 ± 0.18 21 15 25.5 ± 6.1 14 Outside the US MRI safety information - heart valve therapy product.
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Descended from a proven family of PERIMOUNT surgical valves, the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve is the first biomechanically engineered valve designed specifically for the aortic position. It is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis. The Magna Ease aortic valve (Edwards Lifesciences, Irvine, CA) is a third-generation bioprosthetic valve developed as a modification of the well-studied Perimount and Magna valve designs. The Magna Ease aortic valve (Edwards Lifesciences, Irvine, CA) is a third-generation bioprosthetic valve developed as a modification of the well-studied Perimount and Magna valve designs.