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Edwards Prima Plus Stentless Porcine Bioprosthesis

Edwards Prima Plus Stentless Porcine Bioprosthesis

Edwards Prima Plus Stentless Porcine Bioprosthesis

Product catalog summary
Overview: The Edwards Prima Plus Stentless valve, known as the Biograft, combines bioprosthetic valve technology with the flexibility of a homograft. It is designed for easier implantation, orientation, and trimming, which are crucial for stentless valve procedures.
Key Features:
  • Edwards XenoLogiX Treatment: This patented treatment significantly reduces calcification, as demonstrated in animal studies.
  • Low-pressure Fixation Technology: This industry-standard process minimizes collagen waveform alterations and enhances leaflet compliance.
  • Innovative Design: The valve combines bioprosthesis with homograft for a flexible feel and is stentless in its native aortic cylinder.
  • Easier Implantation: Features like a patented trim guide, cylindrical sizers, and an integrated holder simplify the implantation process.
Clinical Insights: The valve's softer feel facilitates implantation, as noted by Dr. Scott Goldman. The valve shows excellent durability based on clinical data up to eight years.
Performance Data:
  • Freedom from Structural Valve Deterioration: The chart indicates high freedom from deterioration over eight years post-aortic valve replacement.
  • Regression of Left Ventricular Mass: Data shows significant improvement from discharge to one year, indicating reduced workload on the left ventricle and improved hemodynamic efficiency.
Specifications: The valve is available in sizes ranging from 19 to 29 mm, with corresponding mounting diameters.
References: The document cites several studies and reports supporting the valve's performance and features.
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Catalog excerpts

Edwards Prima Plus Stentless Porcine Bioprosthesis-1

Edwards Prima Plus Stentless Bioprosthesis The Edwards Prima Plus Stentless valve couples proven bioprosthetic valve technology with the pliability reminiscent of a homograft to form the Biograft. In addition to its unique feel, the Biograft is designed for easier implantation, valve orientation and valve trimming. These features are extremely important in the more technically demanding implantation techniques required by stentless valves. Our Edwards Prima Plus valves feature: ■ “Edwards Prima Plus valve’s softer feel facilitates implantation in comparison to other stentless valves I’ve implanted.” - Dr. Scott Goldman 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 the collagen waveform and increases leaflet compliance. Innovative Design – Bioprosthesis combined with homograft gives the flexible feel of a Biograft. – Stentless valve in its native aortic cylinder. Easier Implantation – Patented trim guide simplifies trimming for subcoronary implantation. – Dedicated cylindrical sizers reliably mirror valve dimensions. – Integrated holder may be used with the Edwards handle for convenience. *No clinical data are available which evaluate the long-term impact of the XenoLogiX treatment in patients.

 Open the catalog to page 1
Edwards Prima Plus Stentless Porcine Bioprosthesis-2

Edwards Prima Plus Stentless Bioprosthesis Model 2500P Regression of Left Ventricular Mass4 Freedom From Structural Valve Deterioration (%) 3 Aortic Valve Replacement - All Patients Edwards Stentless Valve p=0.005 Edwards Prima Plus Stentless valve benefits from the company’s years of unparalleled tissue experience. Based on current clinical data out to eight years, durability results are excellent. This chart of left ventricular mass regression shows improvement from discharge to one year. Regression of hypertrophy is a more direct parameter to quantify the reduced work of the left ventricle...

 Open the catalog to page 2

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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.