Novel 3D Stent Demonstrates Safety and Efficacy in Treatment of PAD
Las Vegas, USA, 11 October 2012. – New data presented today at the annual VIVA (Vascular InterVentional Advances) conference has shown that a stent with unique three-dimensional geometry, BioMimics 3D™, demonstrated an excellent safety profile and promising clinical performance at both six and twelve months in the treatment of patients with peripheral arterial disease (PAD) undergoing femoropopliteal artery intervention.
The MIMICS study is a prospective, randomised controlled trial, conducted at eight German investigational centres, comparing the safety and efficacy of the BioMimics 3D™ stent with a straight nitinol stent (primarily the Bard LifeStent) in patients with PAD undergoing femoropopliteal artery intervention. Fifty patients received treatment with the BioMimics 3D™ stent and 26 received the control stent. At six months, all patients in both treatment groups were free from clinically-driven target lesion revascularisation (CD TLR), and there were no deaths or amputations. Of the 36 patients treated with BioMimics 3D stents who had reached the 12-month follow-up time point, 33 (91.7%) remained free from CD TLR, compared with 18 of the 21 (85.7%) from the control group who reached the same follow-up time point. The independent core lab has not detected any stent fractures to date in either treatment group.
The BioMimics 3D stent features a unique design with curvature that closely mimics the natural helical geometry of the human vascular system. This stent is designed to improve blood flow, potentially conferring a vasoprotective effect, and enhances bio-mechanical performance, to reduce kinking, deformation and subsequent vessel trauma during leg flexion, compared to a standard straight nitinol stent.
“The unique BioMimics 3D™ stent architecture could be applied to all current slotted tube nitinol stents, including DES, potentially improving their long-term stent integrity”, commented MIMICS study Principal Investigator Professor Thomas Zeller, Bad Krozingen, Germany. “The final 12-month results will show if the induction of a swirling flow by the 3D architecture, and therefore an increase in wall shear stress, affects patency.”
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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 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 bio-mechanical performance of, stented vessels.
Pre-clinical studies have shown that BioMimics 3D stent technology may significantly reduce restenosis (the narrowing of stented arterial segments) and confer significant mechanical benefits: the BioMimics 3D stent is more flexible, kink and fracture resistant than conventional counterparts.
Veryan has submitted a CE Mark application for the BioMimics 3D stent.
CAUTION: The BioMimics 3D stent is not available for sale or investigational use in the United States.
For further information, please visit: www.veryanmed.com
About VIVA Physicians
VIVA Physicians is a not-for-profit physician organization dedicated to advancing the field of vascular medicine and intervention through education and research. Since 2003, VIVA Physicians has held an annual multidisciplinary vascular education conference in Las Vegas, Nevada where recognized experts and attendees from around the United States and the world come to learn innovative technologies and therapies for vascular disease to improve vascular patient care.