Endologix Inc. (NSDQ:ELGX) won CE Mark approval for its "expanded offering" of Powerlink stent graft products and PowerFit aortic extensions in the European Union.
The company may now begin marketing and selling 31 new sizes of its Powerlink stent grafts and 18 mm to 32 mm diameter models of the company’s PowerFit aortic extensions across the pond, allowing physicians to treat a wider patient population.
The Food & Drug Administration granted the Irvine, Calif.-based company approval for the devices to hit the market in the U.S. Endologix said it expects a full U.S. launch of the products in the fourth quarter, when at the same time it will have a limited release of the devices in the EU.
The polymer used to make the Powerlink is the subject of a patent infringement lawsuit filed against Endologix by C.R. Bard Inc. (NYSE:BCR), accusing Endologix of infringing a patent for expanded polytetrafluoroethylene stent graft technology. Endologix isn’t letting the lawsuit stop its plans to build that business, however; on Aug. 17 it signed a deal to license a Canadian firm’s balloon expandable stent technology, saying it plans to integrate the technology into the Powerlink.
