SHAPING THE FUTURE OF
n (Life Sciences & Allied Applications / Biology) the mimicking of life using imitation biological systems
MIMICS-2 IDE Study
BioMimics 3D is currently the subject of a U.S. Investigational Device Exemption (IDE) study, MIMICS-2, in the US, Germany and Japan. MIMICS-2 is a prospective, single-arm, multicenter clinical trial of the BioMimics 3D Stent which will enroll 280 subjects in up to 40 sites in the U.S., Germany and Japan.
The U.S. Principal Investigator is Timothy Sullivan, MD, of the Minneapolis Heart Institute at Abbott Northwestern Hospital. The European Principal Investigator is Professor Dr med Thomas Zeller of Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany. The Japanese Principal Investigator is Professor Masato Nakamura of Toho Ohashi Medical Center, Tokyo, Japan.
The purpose of MIMICS-2 is to provide data to support Premarket Approval Applications in US and Japan. The trial 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.
Enrolment is expected to be complete by Qtr 4 2016. (ClinicalTrials.gov identifier: NCT02400905)