Edwards 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 announcement:
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 sternotomy 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 sternotomy 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 sternotomy.
Press release: EDWARDS INTUITY Elite Valve System Receives CE Mark…