Veryan Medical’s MIMICS-3D USA Study Commences to Evaluate BioMimics 3D Stent

December 16, 2020—Veryan Medical announced commencement of the MIMICS-3D USA study, which will evaluate the safety, effectiveness, and performance of the company’s BioMimics three-dimensional (3D) stent in a real-world clinical population of patients undergoing femoropopliteal intervention. The study will enroll 500 patients from 40 sites in a 2-year recruitment period.

The study’s three coordinating Principal Investigators are Sahil Parikh, MD, an interventional cardiologist at Columbia University Medical Center in New York, New York; Miguel Montero, MD, a vascular surgeon at Baylor College of Medicine in Houston, Texas; and Robert Beasley, MD, an interventional radiologist at Mount Sinai Medical Center in Miami Beach, Florida.

The first patient in the study was enrolled by John H. Rundback, MD, at NJ Endovascular & Amputation Prevention in Clifton, New Jersey.

“We have been excited to be involved in this study based upon the impressive clinical data for BioMimics 3D and the unique helical centerline which creates a swirling flow pattern that promotes arterial healing after intervention,” commented Dr. Rundback in Veryan’s press release. “In addition, the truly biomimetic design addresses the unique physical challenges and mechanical stresses inherent in the femoropopliteal arteries. We look forward to continuing to collaborate with the Veryan team as we enroll patients to further enhance the real-world data on the value of the BioMimics 3D stent technology.”

In June 2020, Veryan announced that the 36-month results from the company’s MIMICS-2 study were presented by Professor Thomas Zeller, MD, at CX 2020 Live, the virtual Charing Cross Symposium. MIMICS-2 is a prospective, single-arm, multicenter clinical study evaluating the safety and effectiveness of the BioMimics 3D device in the treatment of patients with symptomatic atherosclerotic disease of the femoropopliteal artery. The study enrolled 271 patients undergoing femoropopliteal intervention at 43 investigational sites in the United States, Japan, and Germany.

In the CX 2020 Live presentation, Prof. Zeller reported that the freedom from clinically driven target lesion revascularization (CD-TLR) at 3 years for the BioMimics 3D stent was 81%, a result that is comparable to the outcomes for drug-coated balloons and drug-eluting stents despite treating more challenging lesions and without the need for lesion preparation. Additionally, subanalyses data showed that the CD-TLR 3-year outcome was independent of the presence of severe calcium, total occlusions, and long lesions.

Veryan Medical stated that the BioMimics 3D stent has a 3D helical shape that imparts natural curvature to the diseased femoropopliteal artery, promoting swirling flow and elevating wall shear, which has been proven to have a protective effect on the endothelium. The helical shape of the device is also designed to facilitate shortening of the stented segment during knee flexion and mitigate the risk of stented segment compression causing localized strains that in a straight stent might lead to stent fracture and chronic vascular injury.