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.
published: October 12, 2012 in: Clinical Studies/Trials, Congresses and Meetings, Vascular