A first subject has been enrolled in Veryan Medical’s MIMICS-2 study, a prospective, single-arm, multicenter clinical trial of the BioMimics 3D Stent System being conducted under US FDA Investigational Device Exemption (IDE).
Featured before on our pages, BioMimics 3D is a nitinol stent with unique three-dimensional helical geometry, developed by UK vascular technologies company Veryan Medical, based on pioneering research by Prof Colin Caro at Imperial College London into the link between blood flow mechanics and vascular disease. The BioMimics 3D nitinol stent has unique helical curvature to impart natural curvature to the diseased artery, promoting secondary (swirling) flow and elevated wall shear stress, which has a protective effect on the endothelium.
The MIMICS-2 clinical trial will enroll 280 subjects in up to 40 sites in the US and Germany. Its purpose is to provide data to support a US Premarket Approval Application (PMA). It will evaluate the BioMimics 3D Stent System against the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery.
The procedure was performed at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany by the European Principal Investigator, Professor Thomas Zeller who was also the PI of the company’s Mimics randomized controlled study.
Professor Zeller commented: “The Mimics study data suggested the existence of a patency protective effect provided by the biomimetic characteristics of the BioMimics 3D stent. I am delighted that we have enrolled the first subject today in MIMICS-2 so that BioMimics 3D can be studied in a larger patient cohort.”
Chas Taylor, CEO, said “After the successful Mimics Study, it is very appropriate that the first MIMICS-2 subject has been enrolled by Professor Zeller. We are excited by the prospect that MIMICS-2 will provide further evidence that this advanced biomimetic stent design offers outstanding benefits in femoropopliteal use and has potential for innovation in many other areas of endovascular intervention.”
Source: Veryan Medical Ltd