Veryan Medical Commences MIMICS-3D Registry

September 15, 2016—Veryan Medical Ltd. announced that the first patient has been enrolled in the MIMICS-3D registry to evaluate the company’s BioMimics three-dimensional (3D) self-expanding stent system in the treatment of peripheral artery disease.

The prospective, multicenter, observational registry will evaluate safety, effectiveness, and device performance within a real-world clinical population in a minimum of 500 patients across Europe. In 2012, the BioMimics 3D stent system received European CE Mark approval in the superficial femoral and proximal popliteal arteries. In the United States, the device is limited to investigational use.

According to the company, the BioMimics nitinol stent features 3D helical geometry that imparts natural curvature to the diseased artery, promoting secondary flow and elevated wall shear stress, which has a protective effect on the vessel’s endothelium.

The helical geometry of the BioMimics 3D femoropopliteal stent is also designed to facilitate shortening of the stented segment during knee flexion and to mitigate the risk of ompression in the stented segment causing localized strains that in a straight stent may lead to stent fracture and chronic vascular injury.

The MIMICS-3D registry's Principal Investigator (PI) is Michael Lichtenberg MD, of Arnsberg, Germany. Dr. Lichtenberg commented in the company’s press release, “Having been able to enroll a significant number of patients into the MIMICS-2 investigational device exemption study, I am delighted to be the PI of the MIMICS-3D registry and particularly pleased to be able to enroll the first patient into the MIMICS-3D registry. The three studies within the MIMICS program will provide a combined database of clinical experience that I expect to provide significant validation of the unique helical shape of BioMimics 3D and the clinical benefits of swirling flow.”