Avinger (NSDQ:AVGR) said today that it won CE Mark approval in the European Union for the next generation of its Pantheris image-guided atherectomy device.
Redwood City, Calif.-based Avinger said the new device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability and tissue storage capacity. It’s designed to treat blocked peripheral blood vessels, using its Lumivascular optical coherence tomography technology.
“CE Marking approval to market and sell our next generation of Pantheris in Europe and other CE Mark countries represents an important milestone which should benefit both patients and physician users of our technology,” president & CEO Jeff Soinski said in prepared remarks. “This next-generation device incorporates the feedback we have received from our physician partners over nearly two years and should deliver the next level of quality, efficiency, and ease of use to the Pantheris atherectomy system. We are excited to initiate our first clinical experiences with the devices in Europe in the near future.”
Last September the company won CE Mark approval for treating in-stent restenosis with Pantheris. In October 2016, Avinger won expanded indications from the FDA for the device for diagnostic imaging as well as treatment for peripheral artery disease.
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