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Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis

Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis

Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis

Product catalog summary
Overview: Edwards Lifesciences' porcine valves are designed with advanced technology and materials to enhance implantation and durability. These valves feature an extended sewing ring for easier implantation when a larger suture surface is needed.
Key Features:
  • Edwards XenoLogiX Treatment: This patented treatment significantly reduces calcification, as demonstrated in animal studies, although long-term patient data is not yet available.
  • Low-pressure Fixation Technology: This industry-standard process minimizes collagen waveform alterations and increases leaflet compliance.
  • Specialized Construction: The asymmetric stent conforms to natural porcine valve geometry, minimizing muscle shelf and preventing orifice obstruction.
  • Extended Sewing Ring: Provides a larger suture surface for easier implantation.
  • Elgiloy Stent: Made from a flexible material that minimizes tissue stress and offers superior spring efficiency.
Product Models:
  • Carpentier-Edwards Duraflex Bioprosthesis Mitral Models 6625LP and 6625-ESR-LP, proven to have 14-year durability in patients over 70 years old.
Specifications:
  • Mounting Diameter (Annulus): 27-35 mm
  • Graft Mounting Diameter (Stent I.D.): 25-33 mm
  • Profile Height varies by model and size
  • External Sewing Ring Diameter varies by model and size
Regulatory and Trademark Information: The device is restricted to sale by or on the order of a physician. Various trademarks are registered by Edwards Lifesciences Corporation.
References: The document cites studies and data supporting the features and durability of the valves.
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Catalog excerpts

Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis-1

Carpentier-Edwards Duraflex Low-Pressure Bioprosthesis Edwards Lifesciences’ porcine valves combine rigorous tissue selection, proven fixation technology and advanced manufacturing components that have set the industry standard. Available with an extended sewing ring, these valves are easier to implant when a larger suture surface is required. Our Duraflex valves feature: New Patented Edwards XenoLogiX Treatment – Significantly reduced calcification in rat and sheep implant studies.1, 2 * Low-pressure Fixation Technology – The Edwards process that has set the industry standard. – Minimizes alterations in collagen waveform and increases leaflet compliance. Specialized Construction – Asymmetric stent conforms to the natural porcine valve geometry. – Minimizing muscle shelf by sewing into the stent wall, prevents obstruction of the orifice. Extended Sewing Ring – Available for larger suture surfaces. Elgiloy Stent – Flexible material minimizes tissue stress. – Superior spring efficiency reduces creep. *No clinical data are available which evaluate the long-term impact of the XenoLogiX treatment in patients.

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Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis-2

Carpentier-Edwards Duraflex Bioprosthesis Proven 14 year Durability in Patients >70 years.3 Edwards TRUE-SIZE Mitral Sizer- Model 1162 Edwards Reusable Handle - Model 1111 Edwards Longer Single-use Handle - Model 1126 Actuarial Freedom From Structural Valve Deterioration at 14 Years ACA/AHA Guidelines recommend 70 years as the Significant dimensions in millimeters (nominal values) B. Graft Mounting Diameter (Stent I.D.) 25 27 29 31 33 D. External Sewing Ring Diameter See instructions for use for full prescribing information. 1. Cunanan C, etal. Tissue Characterization and Calcification Potential...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.