CE Mark for abdominal aortic aneurysm sealing device
Published date : 12 September 2012
Article date : 12 September 2012
Mass Device reports on a press release from Endologix which states that the company has won CE Mark approval for a medical device designed to seal abdominal aortic aneurysms. This is the latest version of the manufacturer's Nellix system.
Apparently, the CE approval does not mean that the device will be available just yet. The press release says that Endologix is implementing enhancements to the Nellix system which are intended to further optimise the device to appeal to the marketplace. When complete, the company will submit the enhancements to its notified body with the expectation of gaining CE Mark approval for the commercial version of the device. This will be followed by a limited market introduction of the system in Europe by the end of the second quarter of 2013.
Source: Mass Device, 10 September 2012
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