Avinger has received CE mark approval for Wildcat – a next-generation catheter used in endovascular procedures for the treatment of peripheral artery disease (PAD).
The device may also be used to facilitate the placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions (CTO)) in the peripheral vasculature prior to further percutaneous intervention.
Avinger recently completed enrollment of the chronic total occlusion crossing with the wildcat catheter (CONNECT) study, an 88 patient IDE study evaluating Wildcat for crossing chronic total occlusions in femoropopliteal lesions, in support of a CTO indication.
Avinger will begin commercialization of Wildcat in select European countries by the end of second quarter of 2011.
Wildcat is commercially available as a guidewire support catheter in the US.