News | Stents Peripheral | July 17, 2015

First Subject Enrolled in Veryan Medical's MIMICS-2 study

Joint U.S./European study will assess safety, effectiveness of BioMimics 3D nitinol stent in treatment of femoropopliteal artery

Veryan Medical, BioMimics 3D femoropopliteal stent, MIMICS-2 study, PAD

July 17, 2015 - Veryan Medical 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, Prof. Thomas Zeller.

The BioMimics 3D femoropopliteal stent is a self-expanding, nitinol stent with unique three-dimensional helical geometry designed to address the link between blood flow mechanics and vascular disease. The stent's helical curvature imparts a 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 BioMimics 3D 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. 

MIMICS-2 is a prospective, single-arm, multicenter clinical trial of the BioMimics 3D Stent System - being conducted under an investigational device exemption (IDE) approved by the U.S. Food and Drug Administration (FDA) - which will enroll 280 subjects in up to 40 sites in the United States and Germany. The U.S. principal investigator is Timothy Sullivan, M.D., 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 U.S. premarket approval application (PMA). It will evaluate BioMimics 3D 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."

In the Mimics Study, the Kaplan Meier (KM) survival estimate of freedom from loss of primary patency at two years was 72 percent for BioMimics 3D subjects vs. 55 percent 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 percent at both time-points) compared to a three-fold increase (8 percent at 12 months and 24 percent at 24 months) in the straight stent control arm.

For more information: www.veryanmed.com

Related Content

Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott While Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Recent Acquisitions Eroding Prices in Billion Dollar European Interventional Cardiology cath lab Market.
Feature | Cath Lab | May 07, 2018 | Simon Trinh and Jeffrey Wong
The European interventional cardiology market is currently valued at nearly $1.4 billion.
Videos | Cath Lab | May 07, 2018
Imran Ahmad, M.D., medical director of interventional cardiology, explains some of the new technologies his labs have
360 Photos | Cath Lab | April 20, 2018
A 360 degree view of the newest cath lab at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., located
SCAI Announces Global Lecture Series for 2018 Scientific Sessions
News | Cath Lab | April 18, 2018
Many of the world’s leading interventional cardiologists and cardiovascular professionals will convene in San Diego,...
Overlay Init