Veryan's BioMimics 3D Stent Shows Promise in Early MIMICS Data

October 11, 2012—Principal Investigator Prof. Thomas Zeller, MD, presented preliminary data from the MIMICS study during a Late-Breaking Trials session at the VIVA 2012: Vascular InterVentional Advances meeting in Las Vegas. MIMICS is a prospective, randomized controlled trial comparing the safety and efficacy of the BioMimics 3D stent (Veryan Medical, Horsham, West Sussex, United Kingdom) with a comparator nitinol stent in patients with peripheral arterial disease undergoing femoropopliteal artery intervention.

Veryan Medical describes the BioMimics 3D stent as featuring a three-dimensional design that closely mimics the natural helical geometry of the human vascular system. The stent is designed to improve blood flow, potentially conferring a vasoprotective effect, and enhance biomechanical performance to reduce risk of kinking, deformation, and subsequent vessel trauma during leg flexion, compared to a standard nitinol stent. In Europe, Veryan has submitted an application for CE Mark approval for the BioMimics 3D stent; in the United States, the device is not available for sale or investigational use.

The MIMICS study was conducted at eight German investigational centers. The phase 1 lead-in cohort was composed of 10 patients, each receiving a BioMimics 3D stent. The phase 2 cohort was randomized 2:1, BioMimics 3D (n = 50) versus a commercially available stent, primarily the LifeStent [Bard Peripheral Vascular, Tempe, AZ] (n = 26), making a total enrollment in both phases of 86 patients.

Follow-up in the study was conducted at 1, 6, 12, and 24 months. Fifty patients treated with BioMimics 3D stents have reached the 6-month follow-up point, and 36 patients have reached the 12-month point.

At VIVA, Prof. Zeller presented preliminary results from the MIMICS study in which the BioMimics 3D stent demonstrated an excellent safety profile and promising clinical performance at both 6 and 12 months (100% and 91.7% freedom from clinically driven target lesion revascularization, respectively). No stent fractures were detected by an independent core lab.

“The unique BioMimics 3D stent architecture could be applied to all current slotted tube nitinol stents including drug-eluting stents, potentially improving their long-term stent integrity,” commented Prof. Zeller. “The final 12-month results will show if the induction of swirling flow by the 3D architecture, and therefore an increase in wall shear stress, affects patency.”