1 July 2015 – Veryan Medical has announced that the first subject has been enrolled in their MIMICS-2 study at Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany by the European Principal Investigator, Professor Thomas Zeller.
MIMICS-2 is a prospective, single-arm, multicenter clinical trial of the BioMimics 3D Stent System being conducted under US Investigational Device Exemption (IDE) approved by FDA, which will enroll 280 subjects in up to 40 sites in the US and Germany. The US Principal Investigator is Timothy Sullivan, MD, Chairman of Vascular/Endovascular Surgery at Minneapolis Heart Institute at Abbott Northwestern Hospital.
The purpose of MIMICS-2 is to provide data to support a US Premarket Approval Application (PMA). It will evaluate the BioMimics 3D Stent System against the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery.
Professor Zeller, who was also the PI of the company’s Mimics randomized controlled study commented: “The Mimics study data suggested the existence of a patency protective effect provided by the biomimetic characteristics of the BioMimics 3D stent. I am delighted that we have enrolled the first subject today in MIMICS-2 so that BioMimics 3D can be studied in a larger patient cohort.” Chas Taylor, CEO, said “After the successful Mimics Study, it is very appropriate that the first MIMICS-2 subject has been enrolled by Professor Zeller. We are excited by the prospect that MIMICS-2 will provide further evidence that this advanced biomimetic stent design offers outstanding benefits in femoropopliteal use and has potential for innovation in many other areas of endovascular intervention.”
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 curvature to impart natural curvature to the diseased artery, promoting secondary (swirling) flow and elevated wall shear stress, which has a protective effect on the endothelium.
The helical geometry of the BioMimics 3D femoropopliteal stent is also designed to enable coil-spring shortening of the stented segment during knee flexion and mitigate the risk of stented segment compression causing localized strains that in a straight stent may lead to stent fracture and chronic vascular injury. In the Mimics Study, 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 Research & Development facility is located in Galway, Ireland. BioMimics 3D is a registered trademark of Veryan Medical Ltd.
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
-Ends-
Media contact:
Richard Kenyon
richard@rkpr.co.uk
+44 7831 569940
Help employers find you! Check out all the jobs and post your resume.
MIMICS-2 is a prospective, single-arm, multicenter clinical trial of the BioMimics 3D Stent System being conducted under US Investigational Device Exemption (IDE) approved by FDA, which will enroll 280 subjects in up to 40 sites in the US and Germany. The US Principal Investigator is Timothy Sullivan, MD, Chairman of Vascular/Endovascular Surgery at Minneapolis Heart Institute at Abbott Northwestern Hospital.
The purpose of MIMICS-2 is to provide data to support a US Premarket Approval Application (PMA). It will evaluate the BioMimics 3D Stent System against the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery.
Professor Zeller, who was also the PI of the company’s Mimics randomized controlled study commented: “The Mimics study data suggested the existence of a patency protective effect provided by the biomimetic characteristics of the BioMimics 3D stent. I am delighted that we have enrolled the first subject today in MIMICS-2 so that BioMimics 3D can be studied in a larger patient cohort.” Chas Taylor, CEO, said “After the successful Mimics Study, it is very appropriate that the first MIMICS-2 subject has been enrolled by Professor Zeller. We are excited by the prospect that MIMICS-2 will provide further evidence that this advanced biomimetic stent design offers outstanding benefits in femoropopliteal use and has potential for innovation in many other areas of endovascular intervention.”
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 curvature to impart natural curvature to the diseased artery, promoting secondary (swirling) flow and elevated wall shear stress, which has a protective effect on the endothelium.
The helical geometry of the BioMimics 3D femoropopliteal stent is also designed to enable coil-spring shortening of the stented segment during knee flexion and mitigate the risk of stented segment compression causing localized strains that in a straight stent may lead to stent fracture and chronic vascular injury. In the Mimics Study, 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 Research & Development facility is located in Galway, Ireland. BioMimics 3D is a registered trademark of Veryan Medical Ltd.
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
-Ends-
Media contact:
Richard Kenyon
richard@rkpr.co.uk
+44 7831 569940
Help employers find you! Check out all the jobs and post your resume.
