Veryan Receives CE Mark Approval for BioMimics 3D Stent

November 16, 2012—Veryan Medical Ltd. (Horsham, West Sussex, United Kingdom) announced that it has received CE Mark approval for the BioMimics 3D stent, which is designed to treat the superficial femoral and proximal popliteal (femoropopliteal) arteries of the leg. Veryan stated that it is now preparing to commercialize the BioMimics 3D stent system in Europe and other markets where CE Mark approval may expedite the registration process.

According to Veryan, the BioMimics 3D stent features a three-dimensional design that mimics the natural helical geometry of the human vascular system. The design is intended to improve characteristics of blood flow in the stented segment that may confer a vasoprotective effect and enhance biomechanical performance, with the prospect that kinking, deformation, and consequential vessel trauma during leg flexion may be reduced compared to a standard nitinol stent.

The company stated that CE Mark approval was based on meeting the primary endpoints of the MIMICS study, a prospective randomized controlled trial comparing the safety and efficacy of the BioMimics 3D stent with a standard nitinol stent in patients with peripheral artery disease undergoing femoropopliteal artery intervention. The BioMimics 3D stent demonstrated an excellent safety profile and promising clinical performance at both 6- and 12-month time points. Follow-up assessments of patients in the MIMICS study will continue for 2 years, advised the company.

Interim MIMICS data were presented at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas in October 2012. At 6 months, all 50 patients that underwent treatment with the BioMimics 3D stent were free from clinically driven target lesion revascularization, and there were no deaths or amputations. Of the 36 patients treated with BioMimics 3D stents who had reached the 12-month follow-up time point, 33 (91.7%) remained free from clinically driven target lesion revascularization compared with 18 of the 21 patients (85.7%) from the control group who reached the same follow-up time point. The independent core lab has not detected any stent fractures to date in either treatment group, according to Veryan.

MIMICS Principal Investigator Prof. Thomas Zeller, MD, of the University Heart Centre, Freiburg-Bad Krozingen, Germany, commented on the device and data in the company's press release.

“Besides reducing the risk of stent fracture, the unique BioMimics 3D stent architecture has been shown in preclinical animal studies to transform a laminar flow into a swirling flow, a phenomenon known to increase wall shear stress, which may mitigate the development of neointimal hyperproliferation,” stated Prof. Zeller. “The 6-month results of the trial have proven the safety of the new stent design, and we are eagerly awaiting the 12-month patency results where we expect at least a positive performance signal.”