Two-Year MIMICS Data Show Long-Term Patency for Veryan's BioMimics 3D Stent

February 3, 2014—Veryan Medical Ltd. (Horsham, UK) announced that 2-year follow-up data from the MIMICS study have shown that the company’s BioMimics 3D nitinol stent with three-dimensional helical geometry provides an improvement in long-term patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention for symptomatic peripheral arterial disease. Veryan has received European CE Mark approval for the BioMimics 3D stent.

The study’s principal investigator, Prof. Thomas Zeller, MD, presented the data on behalf of the MIMICS investigators at LINC 2014: the Leipzig Interventional Course in Leipzig, Germany. Prof. Zeller is from the Universitäts-Herzzentrum Freiburg-Bad Krozingen in Bad Krozingen, Germany. Prof. Zeller presented the first data from the MIMICS trial in October at the VIVA 2013: Vascular Interventional Advances conference in Las Vegas, Nevada. Those data demonstrated the safety and promising clinical performance of the device at 12 months.

The MIMICS study is a prospective, 2:1, randomized, controlled trial conducted at eight German investigational centers with an independent imaging core lab. MIMICS is comparing the safety and efficacy of the BioMimics 3D stent with a straight nitinol stent.

According to Veryan Medical, the MIMICS data presented at LINC showed the Kaplan-Meier (KM) survival analysis of freedom from loss of primary patency at 2 years to be 75.6% for BioMimics 3D subjects versus 56% for the control group (P = .06). The company noted that in line with the preclinical observations, the preliminary 2-year data from the MIMICS study point to a correlation between primary patency and stent curvature as measured using biplanar x-ray imaging in straight- and bent-knee positions. Segments treated with the BioMimics 3D stent showed greater curvature in knee extension (P = .02) and flexion (P = .02) compared with the control, providing a basis for improved hemodynamics that may underlie the longer-term patency protective effect seen with BioMimics 3D. No stent fractures have been detected by the study core lab, advised the company.

In Veryan Medical’s press release, Professor Zeller commented, “The latest 24-month data for patients treated with the BioMimics 3D stent continue to suggest that the flow effects produced by its helical design are contributing to an improved outcome compared to that achieved with the straight control stent. The KM curve for freedom from loss of primary patency with BioMimics in the 12–24 month period shows separation from that of the control stent, with the prospect of a statistically significant difference once the few remaining subjects are assessed over the next 2 months.”

The company stated that the BioMimics 3D stent features a 3D helical centerline curvature to help the stented artery mimic the natural biomechanical performance of the femoropopliteal artery during knee flexion and extension. This stent is also designed to promote swirling blood flow and elevated wall shear stress in the stented segment, which have been shown in preclinical studies to significantly reduce the formation of neointimal hyperplasia, potentially conferring a patency protective effect.

The company anticipates that the full 24-month data set will be available in April 2014.