Avinger, a medical device company focused on the development of cardiovascular devices, has initiated the enrollment of the first patient in the CONNECT (Chronic TOtal OcclusioN CrossiNg with thE WildCat CatheTer) clinical trial.
The CONNECT trial is a prospective, multi-center, non-randomized study intended to evaluate the Wildcat Catheter’s ability to cross chronic total occlusions in femoropopliteal lesions.
The Wildcat Catheter crosses CTO lesions by creating a ‘corkscrew’ effect enabling further treatment of the lesion with therapeutic devices.
Avinger said that the Wildcat Catheter has received FDA 510(k) clearance in February 2009 for use as a guidewire support device to access discreet areas of the vasculature.
Avinger CEO John Simpson said that Avinger was created to develop technologies that change the way vascular disease is treated today and the CONNECT trial will provide clinical data to help guide physicians in the use of the Wildcat and provide expanded treatment options for PAD and they hope that Avinger can play a key role in helping patients facing an amputation keep their leg.