Twelve-Month Data Presented for Veryan's BioMimics 3D Helical Stent

May 21, 2013—Veryan Medical Ltd. (Horsham, West Sussex, United Kingdom) announced that data from the MIMICS study of the company's BioMimics 3D stent with three-dimensional helical geometry demonstrated safety and promising clinical performance at 12 months in the treatment of patients with peripheral arterial disease (PAD) undergoing femoropopliteal artery intervention. Veryan received CE Mark approval for the BioMimics 3D stent in November 2012.

The company noted that the data appear to provide the first clinical substantiation for the hypothesis that a stent with 3D geometric curvature will be patency-protective through stimulation of swirling flow and elevation of wall shear stress. Professor Stephan Duda, MD, presented the MIMICS data at the EuroPCR 2013 meeting in Paris, France. Prof. Duda is a radiologist at Gefäßzentrum am Jüdischen Krankenhaus in Berlin, Germany.

According to Veryan Medical's press release, the MIMICS study is a prospective 2:1 randomized controlled trial conducted at eight German investigational centers. The study was designed to compare the safety and efficacy of the BioMimics 3D stent to a straight nitinol stent (primarily the LifeStent [Bard Peripheral Vascular, Tempe, AZ]) in 76 patients with PAD undergoing femoropopliteal artery intervention.

Veryan Medical stated that the MIMICS data showed the 12-month Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization for patients receiving the BioMimics 3D stent was 91.2%. The 12-month Kaplan-Meier estimate of primary patency was 80.4% for BioMimics 3D subjects versus 72% for the control group. The independent core lab reported no stent fractures in either treatment group.

Prof. Duda commented in the company's announcement, “These results indicate that the unique 3D geometry of the BioMimics 3D stent is biomechanically compliant with the vessel, which likely reduces the incidence of stent fracture and also chronic vascular injury of the unstented segment. We now need additional longer-term data to confirm these effects.”

As noted in Veryan's press release, the device's 3D geometric curvature closely mimics the natural helical geometry of the human vascular system. The stent is engineered to promote swirling blood flow through the stented segment, which preclinical data have shown to significantly reduce the formation of neointimal hyperplasia, potentially conferring a vasoprotective effect through elevation of wall shear stress.

Additionally, the company stated that emerging data from the MIMICS study are pointing to a correlation between 12-month primary patency and stent curvature, measured using biplanar x-ray imaging in straight and bent-knee positions. There was no loss of primary patency above a threshold curvature value of .02 mm^-1.

Veryan Medical advised that swirling flow induced by the BioMimics 3D stent and the resulting levels of wall shear stress are being investigated by ongoing analysis of ultrasound data from the MIMICS study and computational fluid dynamic modeling. Data from the MIMICS study appear to provide the first clinical substantiation for the hypothesis that a stent with 3D geometric curvature will be patency-protective through stimulation of swirling flow and elevation of wall shear stress.

The helical geometry of the BioMimics 3D stent is designed to enhance mechanical performance and biomechanical compatibility and to reduce stent fracture, vessel and stent kinking, deformation, and subsequent vessel trauma during leg flexion compared to straight nitinol stents, stated the company.