Monday, May 11, 2009

Edwards Announces New Cardiac Offerings

Filed under: Cardiac Surgery

jjda3432.jpgEdwards Lifesciences won FDA approval for its new Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, and is also introducing the PORT ACCESS EndoDirect surgery system for minimally invasive cardiac procedures.

Features of the Magna Ease valve from Edwards' EU product page:

  • Low profile facilitates insertion and provides sinotubular junction clearance
  • Low cusp height maximizes coronary ostia clearance
  • Suture markers aid in valve orientation and suture placement
  • Scalloped and compliant sewing ring provides an optimal anatomic fit
  • Compact sewing ring maximizes valve orifice area
  • Industry-leading effective orifice areas (EOAs) and low gradients documented in multiple published studies
  • Magna Ease heart valves include leaflets treated with the Carpentier-Edwards ThermaFix process*—the only dual-action tissue treatment designed to confront both major calcium binding sites
  • Built on the proven performance of PERIMOUNT aortic valves, with durability up to 20 years
  • awe23423.jpg

    About the PORT ACCESS EndoDirect System from the press release:

    Edwards is introducing the PORT ACCESS EndoDirect System, which allows cardiac surgeons to stop a patient's heart and keep it at rest for the duration of the heart valve procedure without an incision down the middle of the chest. In procedures such as mitral valve repair and replacement, the EndoDirect System provides a minimally invasive alternative for direct aortic cannulation when femoral access (groin cannulation) is not an option.

    Company animation describing the Magna Ease and comparing it to the Magna model:

    Link to video of the Magna Ease implantation performed at the University Hospital of Wales...

    Press release: Edwards Lifesciences Receives FDA Approval for New Heart Valve

    Edwards EU product page: PERIMOUNT Magna Ease Aortic Heart Valve

    Flashback: Edwards PERIMOUNT Magna Mitral Valve Gets FDA's Green Light

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