MIMICS Data Presented for Veryan's BioMimics 3D Stent

October 9, 2013—Veryan Medical Ltd. (Horsham, UK) announced that the company's BioMimics 3D stent, which features a three-dimensional (3D) helical geometry, has demonstrated safety and promising clinical performance at 12 months in the treatment of patients with peripheral arterial disease (PAD) undergoing femoropopliteal artery intervention. Principal Investigator Prof. Thomas Zeller, MD, presented the data from the company's MIMICS trial during the Late-Breaking Clinical Trials session at the VIVA 2013: Vascular Interventional Advances conference in Las Vegas, Nevada.

According to Veryan, the MIMICS study is a prospective, 2:1 randomized controlled trial comparing the safety and efficacy of the BioMimics 3D stent to a straight nitinol stent (primarily the LifeStent [Bard Peripheral Vascular, Inc., Tempe, AZ]) in 76 patients with PAD undergoing femoropopliteal artery intervention. The study is being conducted at eight German investigational centers. Professor Zeller is from Universitäts-Herzzentrum Freiburg-Bad Krozingen in Bad Krozingen, Germany.

The company stated that the BioMimics 3D stent's geometric curvature closely mimics the natural helical geometry of the human vascular system. The stent is designed 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.

The data presented at VIVA showed the 12-month Kaplan-Meier (KM) estimate of freedom from clinically driven target lesion revascularization was 91.2% for patients receiving the BioMimics 3D stent. The KM estimate of 12-month primary patency was 80.4% for BioMimics 3D patients versus 72% for the control group (day 365; P = .436). No stent fractures were detected by core lab in the BioMimics 3D and control groups in 12-month x-rays.

Veryan noted that the 12-month MIMICS data point to a correlation between primary patency and stent curvature, measured using biplanar x-ray imaging in straight and bent-knee positions. No loss of stent patency was observed in any subject in whom stent curvature measured > 0.02 mm^-1. Biplanar x-ray imaging and computational fluid dynamic modeling showed increases in both swirling flow (55%; P = .017) and wall shear stress (18%; P = .054) for BioMimics 3D compared to the control. Interim 24-month data show that 76% of BioMimics 3D patients gained a peak systolic velocity ratio improvement between 12 and 24 months, which is 83% more than in the control group (P = .067). The company advised that 24-month follow-up assessments are ongoing.

The company stated that these data provide support for the hypothesis that a stent with 3D geometric curvature will be patency-protective through development of swirling flow and elevation of wall shear stress. The helical geometry of the BioMimics 3D stent also enhances mechanical performance and biomechanical compatibility. It is intended to reduce stent fracture, vessel and stent kinking, deformation, and subsequent vessel trauma during leg flexion, compared to straight nitinol stents.

“Data on the BioMimics 3D stent demonstrating promotion of swirling flow and increased wall shear stress, together with 12-month and emerging 24-month patency data, point to the merit of this innovative approach to stent design for femoropopliteal use,” commented Prof. Zeller in Veryan's press release. “We now need additional longer-term data to confirm these effects.”