Veryan Medical has announced that the first subject has been enrolled in its MIMICS-2 study at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany, by the European principal investigator, Thomas Zeller.
MIMICS-2 is a prospective, single-arm, multicentre clinical trial of the BioMimics 3D stent system being conducted under US investigational device exemption (IDE) approved by the Food and Drug Administration, which will enrol 280 subjects in up to 40 sites in the USA and Germany. The US principal investigator is Timothy Sullivan, chairman of vascular/endovascular surgery at Minneapolis Heart Institute at Abbott Northwestern Hospital, USA.
The purpose of MIMICS-2 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 for the safety and effectiveness of nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery.
Zeller, who was also the principal investigator of the company’s Mimics randomised controlled study 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, chief executive officer, said, “After the successful Mimics study, it is very appropriate that the first MIMICS-2 subject has been enrolled by Thomas 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.”
The BioMimics 3D nitinol stent has unique helical curvature to impart natural curvature to the diseased artery, promoting secondary flow and elevated wall shear stress, which has a protective effect on the endothelium. The helical geometry of the BioMimics 3D femoropopliteal stent is also designed to enable coil-spring shortening of the stented segment during knee flexion and mitigate the risk of stented segment compression causing localized strains that in a straight stent may lead to stent fracture and chronic vascular injury.