Professor Thomas Zeller MD announced new significant outcomes from the Mimics Study today at the 15th Annual Conference on Vascular Interventional Advances (VIVA17) in Las Vegas, NV, USA.
The BioMimics 3D Vascular Stent with unique helical curvature to generate swirling blood flow was evaluated in the Mimics Study, which 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 revascularisation between 12 & 24 months (p=0.03).¹
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.² 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.
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.”
BioMimics 3D Vascular Stent System
The BioMimics 3D stent has unique three-dimensional helical shape, designed to impart natural curvature to the diseased femoropopliteal artery, promoting swirling flow and elevating wall shear, which has a protective effect on the endothelium.³ The helical shape of the BioMimics 3D stent is also designed to facilitate shortening of the stented segment during knee flexion and mitigate the risk of stented segment compression causing localised strains that in a straight stent may lead to stent fracture and chronic vascular injury.4,5
In the Mimics trial, the Kaplan Meier (KM) survival estimate of freedom from loss of primary patency at two years was 72% for BioMimics 3D subjects vs. 55.0% for the control arm. The difference in survival estimate between the two groups by log rank test was significant (p=0.05). Importantly, there was no increase in the KM estimate for clinically driven target lesion revascularization (CDTLR) rate in those subjects treated with BioMimics 3D between 12 and 24 months (9% at both time-points) compared to a 3-fold increase (8% at 12 months and 24% at 24 months) in the straight stent control arm.6
1,6-Zeller T. et al; Circ Cardiovasc Interv. 2016;9:e002930. DOI: 10.1161
²- Data on file at Veryan Medical
³- Zeller T. – Oral Presentation VIVA 2014
4– BH Smouse et al, Endovasc. Today, vol 4, no. 6, pp. 60-66, 2005
5 – Scheinert D et al, J Am Coll Cardiol 2005;45:312–5 doi:10.1016/j.jacc.2004.11.026
About Veryan Medical Ltd.
Veryan’s Head Office is in Horsham, UK and its Research & Development facility is located in Galway, Ireland.
BioMimics 3D is a registered trademark of Veryan Medical Ltd, and the BioMimics 3D Stent System has CE Mark approval.
CAUTION: Investigational Device. Limited by Federal (or United States) Law to Investigational Use.
For further information, please visit: www.veryanmed.com or contact Vicky La Touche-Price at Seroba Life Sciences on +353 (0)1 6334028.