Veryan Medical Announces Milestones in the MIMICS Clinical Program

June 13, 2016—Veryan Medical has announced 2-year results from the MIMICS randomized controlled trial, updated the enrollment figures for MIMICS-2, and shared details on the upcoming commencement of the MIMICS 3D registry.

Findings from the 76-patient MIMICS trial of the company’s BioMimics three-dimensional (3D) helical stent were published by Prof. Thomas Zeller, MD, et al online in Circulation: Cardiovascular Interventions (CCI).

The multicenter trial compared the BioMimics 3D device and a straight bare-metal stent (2:1 randomization) to treat symptomatic disease of the superficial femoral and popliteal arteries. The data published in CCI showed higher patency at 1 and 2 years for the BioMimics 3D helical stent when compared with the control device; the patency rates at 1 and 2 years for the BioMimics stent were 80% and 72%, respectively, versus 71% and 55% in the control arm. Additionally, freedom from clinically driven target lesion revascularization (cd-TLR) was observed in 91% of patients treated with the BioMimics stent at both 1- and 2-year follow-up; the rates of freedom from cd-TLR in the control arm were 92% at 1 year and 76% at 2 years. 

Veryan also announced that the 200th patient has been enrolled in the MIMICS-2 study. MIMICS-2 is a prospective, single-arm, multicenter clinical study of 280 patients at more than 40 investigational sites in the United States, Germany, and Japan. The study is being concurrently allowed under a US Food and Drug Administration investigational device exemption (IDE) and permission of the Japanese Pharmaceuticals and Medical Devices Agency through the Harmonization-by-Doing initiative. The initiative allows the company to provide clinical data to support parallel premarket approval reviews in the United States and Japan.

The BioMimics 3D stent system has CE Mark approval for European marketing. In the United States, the device is limited by federal law to investigational use.

Prof. Zeller, who is the MIMICS-2 German National Principal Investigator commented in the company’s press release, “The outstanding effort and diligence of all investigators and research coordinators is making the MIMICS-2 study the fastest-ever enrolling [superficial femoral artery] stenting study of its type. There is a lot of commitment from everyone involved in this important study, and we eagerly look forward to completing enrollment in the summer.”

Veryan is also anticipating the first patient being enrolled into the company-sponsored MIMICS-3D registry. MIMICS-3D is a prospective multicenter observational registry to evaluate the BioMimics 3D self-expanding stent system in the treatment of peripheral arterial disease. The registry will evaluate safety, effectiveness, and device performance in a real-world clinical population in a minimum of 500 patients across Europe. The MIMICS-3D registry Principal Investigator is Michael Lichtenberg, MD, from Arnsberg, Germany.

Dr. Lichtenberg commented, “Having been able to enroll a significant number of patients into the MIMICS-2 IDE study, I am delighted to be the Principal Investigator of 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 benefits of swirling flow.”