Avinger (NSDQ:AVGR) said today that it won CE Mark approval for treating in-stent restenosis with its Pantheris Lumivascular atherectomy system.
The company’s Lumivascular tech enables physicians to see from inside the artery during a directional atherectomy procedure in real-time, Avinger touted, using optical coherence tomography. The device is designed to help physicians more accurately navigate their devices to treat peripheral artery disease.
“The demand for improved treatment options for in-stent restenosis is growing as physicians experience the accurate visualization and precision provided by state-of-the-art technologies such as the Pantheris Lumivascular atherectomy system,” president & CEO Jeff Soinski said in prepared remarks.
“CE Marking for this particular indication is an important milestone for Avinger that addresses an area of unmet clinical need for patients suffering from PAD. Onboard image guidance coupled with directional plaque excision offers the interventionist clear benefits when treating in-stent restenosis and represents another opportunity to improve patient outcomes.”
“Two elements thoughtful interventionists want to avoid during intervention are adventitia and stent struts,” founder & executive chairman Dr. John Simpson added. “Intravascular visualization combined with a directional mechanism in real time provides operators the information and precision needed to treat only diseased tissue without coming into contact with the stent struts or adventitia.”
