Veryan Medical has announced that the Company has submitted a Premarket Approval (PMA) application for the BioMimics 3D Vascular Stent System to the U.S. Food & Drug Administration (FDA).
Pivotal to the content of the PMA application are the 12-month interim safety and effectiveness results from the Company’s MIMICS-2 clinical study in patients undergoing endovascular intervention to relieve obstructive or occlusive disease in the femoropopliteal artery. BioMimics 3D represents an innovative approach to the requirement for durable support for the arterial
lumen after intervention and the helical centreline stent is designed to promote swirling blood flow and accommodate the complex biomechanical challenge associated with stenting this anatomically mobile artery.
Chas Taylor, Veryan’s Chief Executive Officer commented:
“The achievement of a successful outcome to our pivotal study, which has provided data for our premarket approval applications in US and Japan, is a major milestone for Veryan as we build toward global commercialisation of our BioMimics 3D swirling flow stent.”