Avinger announced on 7 March 2013 the designation of the primary investigators for its upcoming global VISION pivotal study evaluating Pantheris.
The primary co-investigators will be James Bennett, interventional cardiologist, William Crowder, interventional cardiologist, and Huey B McDaniel, vascular surgeon, all of Mississippi Heart and Vascular Institute at St Dominic’s in Jackson, USA, and Arne Schwindt, vascular surgeon, St Franziskus Hospital in Muenster, Germany.
The VISION trial is a multicentre, non-randomised global clinical study designed to evaluate the safety and efficacy of Pantheris, the first-ever image-guided atherectomy device for use in lumivascular procedures using real-time optical coherence tomography. Pantheris combines directional atherectomy capabilities with real-time visualisation to remove plaque with precision from arteries affected by peripheral arterial disease.
Avinger expects to begin enrolment in VISION in the second half of 2013 pending regulatory review and approval.