Avinger this week announced it received FDA 510(k) clearance for its Ocelaris image-guided chronic total occlusion crossing system.
The device will be marketed under the brand name TigerEye and will provide real-time imaging from inside the vessel during CTO-crossing procedures.
“We are excited to receive U.S. pre-marketing clearance for TigerEye, which we believe will be a significant growth driver for our CTO-crossing business,” president and CEO Jeff Soinski said in a news release. “Our Ocelot catheters have helped physicians cross thousands of CTOs since the introduction of the product line in 2013. TigerEye brings compelling new features and benefits to expand upon this platform to help physicians safely cross challenging CTOs. We anticipate initiating a limited launch of TigerEye in the U.S. in the fourth quarter of this year, then leveraging our growing commercial infrastructure and installed base of Lumivascular accounts for a national launch in early 2021.”
TigerEye uses the company’s Lumivascular technology to allow physicians to see from inside the artery during an atherectomy or CTO crossing procedure using an optical coherence tomography that is displayed on Avinger’s Lightbox console. Using the Lumivascular approach, physicians are able to accurately navigate devices and treat peripheral artery disease lesions without exposing healthcare workers and patients to the negative effects of ionizing radiation.
“The FDA clearance of TigerEye provides another market growth opportunity for Avinger, further building on the market gains we have made with our Pantheris Next Generation and Pantheris SV catheters. TigerEye will be the third new product released by Avinger in less than 3 years, putting us on the leading edge of innovation for PAD therapy. We have grown our commercial sales team and advanced our clinical studies to drive case activity and build data in support of our image-guided approach. The company has a robust pipeline of new products and a strong balance sheet with more than $25 million in cash to fuel our product launch and growth plans,” Soinski said.
“I believe that TigerEye represents a major advancement for patients with chronic total occlusions, which presents one of the most significant technical challenges to physicians treating peripheral artery disease. By combining real-time intravascular imaging and the ability to precisely control the device within the vessel, TigerEye provides an important new tool to help interventionalists stay within the true lumen while successfully crossing these challenging lesions. Intraluminal crossing provides for a wider variety of treatment options following crossing of the CTO and results in less potential for vascular injury, which has been shown to improve long-term clinical outcomes for patients,” chief medical officer Jaafer Golzar said.