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MagNa PerForMaNce MiTraleaSe

MagNa PerForMaNce MiTraleaSe

MagNa PerForMaNce MiTraleaSe

Product catalog summary
Overview: The document discusses the Magna Mitral Ease, a pericardial bioprosthesis designed for mitral valve replacement. It highlights the valve's performance, durability, and design enhancements that facilitate implantation.
Specifications: The Magna Mitral Ease valve is available in various sizes with specific dimensions for stent diameter, tissue annulus diameter, external sewing ring diameter, and anterior effective profile. The valve features a wide, saddle-shaped cuff to mimic annular anatomy and a retractable stent post to minimize entrapment risks.
Performance and Durability: The valve is noted for its long-term endurance, outperforming other designs in both challenging and standard age groups. Studies demonstrate high actuarial freedom from structural valve deterioration over periods extending up to 16 years.
Design Enhancements: Key features include a long, multi-bend handle for enhanced reachability, a unique suture guide for simplified suture placement, and a single-cut handle for quick release. The valve's ultra-low profile optimizes outflow hemodynamics and physiologic flow.
Warnings and Contraindications: The document advises caution in patients with conditions affecting calcium metabolism or those on calcium-containing therapies. It also warns against use in cases where patient longevity exceeds the prosthesis's known longevity.
Clinical Data: No clinical data are available evaluating the long-term impact of the Carpentier-Edwards ThermaFix process in patients.
Accessories: The document lists accessory sets for valve sizing, including the Barrel Sizer Accessory Set and the Replica Sizer Accessory Set.
Legal and Trademark Information: The document includes legal disclaimers and trademark information related to Edwards Lifesciences Corporation.
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Catalog excerpts

MagNa PerForMaNce MiTraleaSe-1

MAGNA MITRAL EASE Pericardi al B i o p r o st he s i s

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MagNa PerForMaNce MiTraleaSe-2

Where Magna per Built on Proven Performance The Magna Mitral Ease valve offe • Outperforming mitral pericardial design in design enhancements for better a count on to ease the challenges o Actuarial Freedom from SVD < 60 age group – Freedom at 10 years PERIMOUNT 84.0% ± 3.7 C-E Porcine 64.7% ± 3.3 Long, multi-bend handle PERIMOUNT mitral valve, model 6900 Carpentier-Edwards porcine mitral valve, model 6650† Actuarial Freedom from SVD 61-70 age group Freedom at 10 years PERIMOUNT 95.2% ± 2.1 C-E Porcine 75.2% ± 3.7 Single-cut handle PERIMOUNT mitral valve, model 6900 Carpentier-Edwards porcine...

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MagNa PerForMaNce MiTraleaSe-3

formance meets Mitral Ease of implant. ers outstanding performance and durability. With the addition of significant access, placement, and suturing, Magna Mitral Ease provides performance you can of mitral valve replacement. Enhanced Mitral Implantability ThermaFix process* anticalcification technology • olor-coded valve C holder confirms implant readiness Retractable stent posts to minimize the potential for entrapment position the posterior strut away from LV wall LVOT reference markers ensure optimal orientation reduce the risk of LVOTO and ventricular injury -shaped cuff • ltra-low profile...

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Model 7300TFX Nominal Specifications (mm) Size A. Stent Diameter (Wireform) B. Tissue Annulus Diameter C. External Sewing Ring Diameter D. Anterior Effective Profile Accessories Barrel Sizer Accessory Set Replica Sizer Accessory Set Pre-attached barrel and replica sizers facilitate valve sizing 27.6 cm Model 6650 does not have market clearance in the USA. References 1. amieson, WRE, et al. Structural Valve Deterioration in Mitral Replacement Surgery: Comparison of Carpentier-Edwards J Supra-Annular Porcine and PERIMOUNT Pericardial Bioprostheses. J Thorac Cardiovasc Surg. 1999 Aug;118:297-305....

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