Intravascular imaging technology developer Avinger has completed patient enrollment for its CONNECT II global clinical trial.
Focused on peripheral arterial disease (PAD), CONNECT II will evaluate Ocelot, an interventional chronic total occlusion (CTO) crossing catheter that uses optical coherence tomography (OCT) imaging technology.
Avinger said it would present CONNECT II aggregate results at the Vascular Interventional Advances (VIVA) conference in October and file a 510(k) application with the U.S. Food and Drug Administration (FDA) later this summer. It expects to receive 510(k) clearance in late 2012.
Avinger has also requested FDA approval to enroll and treat an additional 125 patients in a continued-access cohort. This would ensure that Ocelot is available for use at U.S. CONNECT II sites during the 510(k) review period, the company said.
