Edwards INTUITY Elite Minimally Invasive Aortic Valve System Green Lighted in Europe
 

Edwards INTUITY Elite Minimally Invasive Aortic Valve System Green Lighted in Europe
http://cdn.medgadget.com/wp-content/...lite-valve.jpgEdwards Lifesciences just received CE Mark approval for its new INTUITY Elite aortic valve prosthesis. The device utilizes a balloon-expandable frame with the firm’s 25-year-old Carpentier-Edwards*pericardial PERIMOUNT platform.

The implant comes with a new, lower profile delivery system that allows for smaller incisions in preparation for delivery. More from the an**uncement:

Data from 100 patients in the CADENCE-MIS trial, a randomized, controlled, multi-center trial comparing minimally-invasive AVR with the EDWARDS INTUITY valve system to full ster**tomy AVR with any conventional bioprosthetic aortic valve, were recently presented at the 2014 Annual Meeting of the Society of Thoracic Surgeons (STS). The trial found:

• Minimally-invasive AVR with the EDWARDS INTUITY platform demonstrated a statistically significant reduction (24 percent) in ischemic time (the amount of time blood flow to and from the heart is stopped during surgery) compared to the full ster**tomy approach with conventional bioprosthetic valves. These results are especially meaningful as minimally-invasive approaches have traditionally been associated with longer ischemic times; and
• Improved blood flow and hemodynamics with the EDWARDS INTUITY valve compared to conventional bioprosthetic valves at 3-month follow-up.

Additionally, an interim analysis of 158 patients undergoing isolated aortic valve replacement in the prospective, multicenter, single-arm TRITON Trial(1) for the EDWARDS INTUITY platform, found that 55 percent were performed through a minimally invasive approach, as opposed to a full ster**tomy.

Flashback:*EDWARDS INTUITY Valve System Cleared in Europe…

Press release: EDWARDS INTUITY Elite Valve System Receives CE Mark…

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