Wirion filter system for Stroke Prevention filed with FDA-Allium Medical

Allium Medical announced that it has filed an application to the FDA for clearance of the Wirion filter system. The FDA indication is for use of the system during carotid catheterization procedures for Stroke Prevention. The application was submitted in the 510(k) regulatory track based on the interim clinical data. In parallel, the company continues the enrollment of 120 additional patients in the clinical study according to the study protocol.