New data, published today, points to a statistically significant difference in primary patency at 24 months comparing the helical BioMimics 3D stent with a straight control.
The BioMimics 3D stent has unique three-dimensional helical shape, designed to impart natural curvature to the diseased femoropopliteal artery. The result is a combination of swirling flow and elevating wall shear, which has a protective effect on the endothelium. The helical shape of the BioMimics 3D stent is also designed to facilitate shortening of the stented segment during knee flexion. The design also mitigates the risk of stented segment compression causing localised strains that in a straight stent may lead to stent fracture and chronic vascular injury.
The Mimics Study randomised 76 patients with symptomatic peripheral arterial disease, 2:1 to either BioMimics 3D swirling flow stent or LifeStent® (Bard Peripheral Vascular, Tempe, AZ). A statistically significant difference was observed in primary patency through 24 months (p=0.05) between BioMimics 3D and the straight stent control and in clinically-driven target lesion revascularization between 12 & 24 months (p=0.03).
A post-hoc analysis was conducted to assess how performance of the BioMimics 3D stent was affected by the outcome-confounding factors of calcification, lesion length, occlusion and diabetes. The presence of target lesion calcification did not affect curvature of the BioMimics 3D stented segment nor the generation of swirling flow within.
Kaplan-Meier survival estimates for freedom from loss of primary patency through 24-months in femoropopliteal segments treated with BioMimics 3D stents demonstrate independence from each of the confounding factors of severity of calcium, lesion length, occlusion and diabetes. Professor Zeller commented that the Mimics’ randomized controlled trial data support use of the BioMimics 3D swirling flow stent in primary stenting of complex lesions and point to potential for complementary use with DCBs.
The study was presented at the 15th Annual Conference on Vascular Interventional Advances (VIVA17) in Las Vegas, NV.
Chas Taylor, Veryan’s CEO said, “Further MIMICS studies are underway in US, Europe and Japan to provide an evolving and substantial database of safety and effectiveness outcomes in more than 1300 subjects undergoing femoropopliteal intervention.”
Source: Veryan Medical