AtriCure (NSDQ:ATRC) said yesterday that it won 510(k) clearance from the FDA for its AtriClip Flex V left atrial appendage closure device, touting it as the first AtriClip device with a trigger release for deployment.
“The AtriClip Flex V is an exciting new product that we are pleased to be releasing to our U.S. customers,” president & CEO Mike Carrel said in prepared remarks. “This product will enable easier AtriClip deployment in open-chest surgeries, as it combines the lower-profile “V” clip technology with a redesigned handle enabling a one-handed operation of the device. To date, we have successfully placed over 200 AtriClip Pro V devices since we launched in September of 2017, and this innovation builds off that momentum. We are excited to see how many more patients we can impact with the addition of the AtriClip Flex V to the AtriClip franchise.”
Mason, Ohio-based AtriCure won 510(k) clearance for the original AtriClip device back in mid-2010. The device’s full name is the AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion System, after former Cleveland Clinic CEO Dr. Toby Cosgrove and the clinic’s Dr. Marc Gillinov.
The post ActriCure launches AtriClip Flex V left appeared first on MassDevice.
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