Interim data show benefit of 3D helical vascular stent

Thomas Zeller

LAS VEGAS — Interim data from the MIMICS-3D registry demonstrated early safety and effectiveness of a 3D helical vascular stent in challenging, real-world patients with femoropopliteal disease.

Thomas Zeller, MD, PhD, head of the department of angiology at the University Heart Center Freiburg-Bad Krozingen in Germany, reported at VIVA 18 data on the first 200 of 505 patients enrolled in the MIMICS-3D European registry who were treated with the BioMimics 3D vascular stent system (Veryan Medical).

The primary safety endpoint, a composite of major adverse events comprising death, major amputation of the index limb or clinically driven target lesion revascularization through 30 days, was 1%. No deaths occurred. The primary effectiveness endpoint, freedom from clinically driven TLR through 12 months, was 90.2%. Additionally, 88.5% of patients showed improvement of at least one or more Rutherford category compared with baseline.

The BioMimics 3D stent was evaluated in the MIMICS randomized controlled trial, which demonstrated better primary patency compared with a straight stent. A second study, MIMICS-2, conducted in the U.S., Japan and Europe, met 30-day safety and 12-month primary patency endpoints. Longer-term data are accruing in the ongoing follow-up through 3 years.

The MIMICS-3D registry is evaluating outcomes in more challenging patients with longer, more complex lesions. The mean lesion length was 125 mm and mean stented segment length was 129 mm in the first 200 patients studied. Zeller said this was an open study “without any lesion length limitation.” One-quarter of patients presented with critical limb ischemia, one-third with diabetes and the degree of calcification was significant. Fifty percent of lesions had been pre-treated with a drug-coated balloon.

Overall technical success was 98%.

No stent fractures occurred in this registry, or in the other studies of this stent.

“Data from three MIMICS studies support the hemodynamic, biomechanical and clinical benefits of the BioMimics 3D swirling stent flow design,” Zeller said at VIVA 18.

BioMimics 3D is a nitinol stent designed with the addition of a 3D helical centerline that provides biomechanical stability and swirling blood flow.

“The design guarantees a change in the shape of the artery,” compared with a straight stent, Zeller said.

Discussing the findings during a press conference, Zeller noted that the MIMICS data show that the restenosis rate and reintervention rate appears to flatten out after 1 year, beyond which there is no additional TLR.

“In the longer term, it could be that the change in vessel shape might positively impact reintervention rates,” he said.

In October, the FDA approved the BioMimics 3D stent for treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery.

Veryan Medical announced in June that enrollment completed for the 500th patient in the MIMICS-3D European registry. – by Katie Kalvaitis

Reference:

Zeller T, et al. Late-Breaking Clinical Trials. Presented at: VIVA 18; Nov. 5-8, 2018; Las Vegas.

Disclosure: Zeller reports he received honoraria from, consulted for and held common stock in Veryan/Novate.