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04-05-2014, 01:14 AM
Edwards INTUITY Elite Minimally Invasive Aortic Valve System Green Lighted in Europe
http://cdn.medgadget.com/wp-content/uploads/2014/04/Edwards-INTUITY-Elite-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… (http://www.medgadget.com/2012/02/edwards-intuity-valve-system-cleared-in-europe.html)
Press release: EDWARDS INTUITY Elite Valve System Receives CE Mark… (http://www.edwards.com/newsroom/Pages/NR20140404.aspx)
http://feeds.feedburner.com/~ff/Medgadget?d=yIl2AUoC8zA (http://feeds.feedburner.com/~ff/Medgadget?a=EGhl6tjATJk:YYfjgU4YsJI:yIl2AUoC8zA) http://feeds.feedburner.com/~ff/Medgadget?d=qj6IDK7rITs (http://feeds.feedburner.com/~ff/Medgadget?a=EGhl6tjATJk:YYfjgU4YsJI:qj6IDK7rITs) http://feeds.feedburner.com/~ff/Medgadget?i=EGhl6tjATJk:YYfjgU4YsJI:gIN9vFwOqvQ (http://feeds.feedburner.com/~ff/Medgadget?a=EGhl6tjATJk:YYfjgU4YsJI:gIN9vFwOqvQ)
http://feeds.feedburner.com/~r/Medgadget/~4/EGhl6tjATJk
http://cdn.medgadget.com/wp-content/uploads/2014/04/Edwards-INTUITY-Elite-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… (http://www.medgadget.com/2012/02/edwards-intuity-valve-system-cleared-in-europe.html)
Press release: EDWARDS INTUITY Elite Valve System Receives CE Mark… (http://www.edwards.com/newsroom/Pages/NR20140404.aspx)
http://feeds.feedburner.com/~ff/Medgadget?d=yIl2AUoC8zA (http://feeds.feedburner.com/~ff/Medgadget?a=EGhl6tjATJk:YYfjgU4YsJI:yIl2AUoC8zA) http://feeds.feedburner.com/~ff/Medgadget?d=qj6IDK7rITs (http://feeds.feedburner.com/~ff/Medgadget?a=EGhl6tjATJk:YYfjgU4YsJI:qj6IDK7rITs) http://feeds.feedburner.com/~ff/Medgadget?i=EGhl6tjATJk:YYfjgU4YsJI:gIN9vFwOqvQ (http://feeds.feedburner.com/~ff/Medgadget?a=EGhl6tjATJk:YYfjgU4YsJI:gIN9vFwOqvQ)
http://feeds.feedburner.com/~r/Medgadget/~4/EGhl6tjATJk