PAD Study Hints At Benefits Of 3D Stent Technology At 12 Months

In short

Clinical study results presented this week are being touted as support for the theory that by inducing a three dimensional component into a mechanical stent, its flow characteristics will mimic the natural geometry of human vessels. In so doing, the so-called secondary blood flow dynamic, effectively a swirling effect, is thought to actively prevent atheroma deposition. Early 12 month results suggest  modestly improved patency compared with a straight stent comparator.

Background

New data has been presented at this week’s annual (Vascular InterVentional Advances (VIVA) conference relating to a stent with unique three-dimensional geometry. Veryan Medical’s  novel BioMimics 3D™ features a unique design with curvature that closely mimics the natural helical geometry of the human vascular system. This stent is designed to improve blood flow, potentially conferring a vasoprotective effect, and is claimed to enhance bio-mechanical performance, to reduce kinking, deformation and subsequent vessel trauma during leg flexion, compared to a standard straight nitinol stent.

The so-called MIMICS study is a prospective, randomised controlled trial, conducted at eight German investigational centres, comparing the safety and efficacy of the BioMimics 3D™ stent with a straight nitinol stent (primarily the Bard LifeStent) in patients with PAD undergoing femoropopliteal artery intervention. Fifty patients received treatment with the BioMimics 3D™ stent and 26 received the control stent. At six months, all patients in both treatment groups were free from clinically-driven target lesion revascularisation (CD TLR), 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 CD TLR, compared with 18 of the 21 (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.

Investigator comments 

“The unique BioMimics 3D™ stent architecture could be applied to all current slotted tube nitinol stents, including DES, potentially improving their long-term stent integrity”, commented MIMICS study Principal Investigator Professor Thomas Zeller, Bad Krozingen, Germany. “The final 12-month results will show if the induction of a swirling flow by the 3D architecture, and therefore an increase in wall shear stress, affects patency.”

Source:  Veryan Medical Ltd.