London, UK, 09 June 2020
Professor Thomas Zeller (University Heart Centre Freiburg, Bad Krozingen, Germany) today presented the 36-month results from Veryan Medical’s MIMICS-2 study at CX 2020 Live.
MIMICS-2
MIMICS-2 is a prospective, single-arm, multi-centre clinical study to evaluate the safety and effectiveness of the BioMimics 3D® Vascular Stent System in the treatment of patients with symptomatic atherosclerotic disease of the femoropopliteal artery. Conducted under an FDA Investigational Device Exemption (IDE) with concurrence of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) under the FDA/PMDA Harmonization By Doing collaboration, MIMICS-2 enrolled 271 subjects undergoing femoropopliteal intervention across 43 investigational sites in US, Japan and Germany. Professor Zeller, along with Dr Timothy Sullivan (Minneapolis, USA) and Professor Masato Nakamura (Tokyo, Japan), is a co-Principal Investigator.
Professor Zeller announced in the first presentation of the 36 month results, that the freedom from CDTLR at 3 years for the BioMimics 3D stent was 81%, a result that is comparable to the outcomes for DCB, DES and Supera, despite treating more challenging lesions and without the need for lesion preparation – providing ease-of-use simplicity and long-term benefits. Furthermore, sub-analyses presented, show that the CDTLR 3 year outcome was independent of the presence of severe calcium, total occlusions and long lesions.
Nick Yeo, Veryan’s CEO commented “These are reproducible, rigorous and high quality data from the US, Japan and Europe and we are delighted that the MIMICS-2 results reinforce those from our earlier MIMICS-RCT study in a larger, more challenging patient population. The outcomes are comparable to those reported for drug eluting stents and drug coated balloons and suggest that mobilising natural swirling flow is an alternative anti-restenosis strategy to the use of antiproliferative drugs. We would like to thank the Principal Investigators of MIMICS-2; and all the investigators and research teams that participated in the study. The combined results from these studies and other ongoing investigations support our belief that BioMimics 3D offers an important solution for treating femoropopliteal artery disease, reducing the burden of re-intervention for the patient and the health care system“.
BioMimics 3D Vascular Stent System
The BioMimics 3D stent has a 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.1 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.2,3
About Veryan Medical Ltd.
Veryan is an Otsuka Medical Devices company.
Veryan's Head Office is in Horsham, UK and its Research & Development facility is located in Galway, Ireland.
BioMimics 3D and Swirling Flow are registered trademarks of Veryan Medical Ltd.
The BioMimics 3D stent has CE Mark and premarket approval (PMA) in US and Japan.
For further information, please visit: www.veryanmed.com
Media Contact: Vanessa Lee. Email: vanessa.lee@veryanmed.com
References
- Zeller T. - Oral Presentation VIVA 2014
- BH Smouse et al, Endovasc. Today, vol 4, no. 6, pp. 60-66, 2005
- Scheinert D et al, J Am Coll Cardiol 2005;45:312-5 doi:10.1016/j.jacc.2004.11.026