Redwood City, Calif — Avinger, Inc, medical device manufacturer of multi-functional catheters for treating patients with peripheral artery disease (PAD), announced that it has successfully completed enrollment in its CONNECT (Chronic TOtal OcclusioN CrossiNg with thE WildCat CatheTer) clinical trial, a prospective, multi-center, non-randomized study to evaluate its Wildcat Catheter’s ability to cross chronic total occlusions in femoropopliteal lesions which is the leading cause of amputations associated with PAD in the United States.
Avinger’s Wildcat Catheter received FDA 510(k) clearance in February 2009 for use as a guidewire support device to access discreet areas of the vasculature. Avinger conducted this study to secure FDA clearance for an indication specific to crossing CTOs. Patients with peripheral artery disease may have chronic total occlusions that are sometimes difficult to treat with endovascular therapy resulting in either bypass surgery or amputation.
"This is a great day for Avinger and a huge accomplishment for our entire team," said Avinger founder and CEO, John B. Simpson, PhD, MD. "We have a lot of work to do but this is a giant step forward for our organization. A lot of people put in a lot of long hours to complete this trial and we can’t thank them enough. We’d like to thank our investigating physicians and their phenomenal staffs and the patients that participated in CONNECT."
Co-Principal investigator for the trial, Dr. M. Laiq Raja of El Paso Cardiology Associates, commented, "I am confident that Wildcat will make a great impact on approaching and successfully crossing long CTO lesions."
The CONNECT study evaluated 88 patients with femoropopliteal CTO lesions at 15 centers in the United States. Patients were followed for 30 days post procedure and an independent group of physicians is currently reviewing the angiographic results to determine crossing efficacy and safety endpoints.
SOURCE: Avinger
