BioMimics 3D US launch

Veryan Medical (Horsham, UK) today announced that it has launched the innovative BioMimics 3D Vascular Stent System in the US. The BioMimics 3D self-expanding, nitinol stent features a highly-differentiated, helical centre-line design that has achieved excellent clinical outcomes in clinical trials, including a pivotal study with 3-year follow-up.

01 September 2020Nick Yeo, Veryan’s CEO commented: “Launching BioMimics 3D in the US marks a significant landmark for Veryan. In preparation for this important commercial step, we have recruited a senior sales team, highly experienced in percutaneous vascular intervention, led by Joe DeJohn, Veryan’s US-based, Chief Commercial Officer. I am confident that in building our commercial organisation on such strong networked foundations, supported by a major, real-world Registry study that we expect to launch in US next Quarter, we will quickly establish BioMimics 3D as the go-to stent for femoropopliteal intervention in the US.”The benefits of the BioMimics 3D stent design have been well established in the MIMICS clinical research program, enrolling more than 1750 patients worldwide. The most recent findings are the 3-year follow-up data from the MIMICS-2 study which were presented by Professor Thomas Zeller (University Heart Center Freiburg, Bad Krozingen, Germany) at CX 2020 Live in June. MIMICS-2 is a prospective, single-arm, multicentre study that evaluated the safety and effectiveness of the BioMimics 3D Vascular Stent System in the treatment of patients with symptomatic atherosclerotic disease of the femoropopliteal artery.Professor Zeller reported at CX 2020, that the 3-year freedom from clinically-driven target lesion revascularization (CDTLR) for BioMimics 3D was 81%; a result that is comparable to outcomes with drug-coated and latest generation bare nitinol stents, despite treating more challenging lesions and without the need for lesion preparation. BioMimics 3D thus provides increased procedural simplicity for physicians, and durable, long-term clinical outcome benefit for patients.1Professor Zeller commented: “I have been using BioMimics 3D routinely in my clinical practice for several years and I am delighted that my US colleagues will also now have this opportunity. The 3-dimensional helical shape of the stent promotes swirling blood flow, a protective phenomenon that occurs naturally in the vasculature, but which can be disrupted, predisposing to atherosclerotic disease and neointimal formation at the site of vascular intervention that can lead to restenosis and the need for re-intervention.2 Data from the MIMICS Clinical Program, including those from our MIMICS Randomized Clinical Trial, comparing the performance of the helical-shaped BioMimics 3D to that of a straight stent, support the clinical benefits of Veryan’s unique stent design that promotes swirling blood flow and improves biomechanical performance in the stented segment.3 I’m sure that the stent will not just be a valuable addition to my US colleagues’ treatment options, but for many will become their primary therapy for femoropopliteal disease.”BioMimics 3D Vascular Stent SystemThe BioMimics 3D stent has a unique 3-dimensional helical shape, designed to impart natural curvature to the diseased femoropopliteal artery, promoting swirling flow and elevating wall shear, which has been proven to have a protective effect on the endothelium.2 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.4,5About Veryan MedicalVeryan became an Otsuka Medical Devices company in December 2018 and applies design intelligence to create medical devices for vascular intervention that improve patient care through a combination of imagination, intuition and innovation. Veryan has offices in Horsham, UK, and Galway, Ireland, the location of the Veryan Innovation Centre that houses the Company’s R&D activities. Veryan has direct sales teams in Germany and the US and has appointed distributors in other markets. The BioMimics 3D Vascular Stent System has Premarket Approval in US and Japan and CE Mark approval in Europe. BioMimics 3D and Swirling Flow are registered trademarks of Veryan Medical Ltd. For more information: Veryan Medical Ltd. www.veryanmed.comVanessa Lee, Marketing Director Vanessa.lee@veryanmed.com References1. Zeller T. Oral Presentation CX Live 20202. Caro et al. 2013 J R Soc Interface 10: 201305783. Zeller T. et al; Circ Cardiovasc Interv. 2016;94. BH Smouse et al, Endovasc. Today, vol 4, no. 6, pp. 60-66, 20055. Scheinert D et al, J Am Coll Cardiol 2005;45:312-5