Veryan Premarket Approval

Veryan announces first patient enrolment into MIMICS-3D Registry

MIMICS-3D is a prospective, multicentre, observational registry to evaluate the BioMimics 3D Self-Expanding Stent System in the treatment of peripheral arterial disease. The Registry will evaluate safety, effectiveness and device performance within a real-world clinical population in a minimum of 500 patients across Europe.

The MIMICS-3D Registry PI, Michael Lichtenberg MD (Arnsberg, Germany) commented: “Having been able to enroll a significant number of patients into the MIMICS-2 IDE Study I am delighted to be the PI of the MIMICS-3D Registry, and particularly pleased to be able to enrol the first patient into the MIMICS-3D Registry. The three studies within the MIMICS programme will provide a combined database of clinical experience that I expect to provide significant validation of the unique helical shape of BioMimics 3D and the clinical benefits of swirling flow.”

Chas Taylor, Veryan CEO commented: “This milestone is another significant step in the Veryan clinical programme. Veryan is committed to seeking high quality, compelling clinical data for our BioMimics 3D stent. We have been overwhelmed by the enthusiasm shown across Europe by clinicians wishing to participate in the MIMICS-3D Registry which illustrates the growing understanding of, and belief in, the clinical benefits of swirling flow.”

BioMimics 3D Stent System

BioMimics 3D, a nitinol stent with unique three-dimensional helical geometry, has been developed by Veryan, based on pioneering research by Prof Colin Caro at Imperial College London into the link between blood flow mechanics and vascular disease. The BioMimics 3D nitinol stent has unique helical shape to impart natural curvature to the diseased artery, promoting secondary (swirling) flow and elevated wall shear stress, which has a protective effect on the vessel’s endothelium. The helical geometry of the BioMimics 3D femoropopliteal 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. 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 of clinically driven target lesion revascularization (CDTLR) rate in the BioMimics arm 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.

About Veryan Medical Ltd.

Veryan is developing innovative solutions to improve the performance of vascular stents using the principles of biomimicry. Veryan’s BioMimics 3D® stent technology involves adapting traditional straight stent designs to a patented three-dimensional helical shape, which more closely mimics the natural geometry of the human vascular system. BioMimics 3D technology is designed to enhance clinical performance by improving flow conditions in, and biomechanical performance of, stented vessels. The advanced, biomimetic design of the BioMimics 3D stent is intended to provide more flexibility, kink and fracture resistance than other laser-cut nitinol tube stents, making its unique design of particular importance in the hostile environment of the femoropopliteal artery. 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 for European marketing.

CAUTION: Investigational Device. Limited by Federal (or United States) Law to Investigational Use.
For further information, please visit: www.veryanmed.com

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