Meeting News

Novel ‘3-D’ stent system safe, effective in femoropopliteal disease

HOLLYWOOD, Fla. — One-year data from the MIMICS-2 trial demonstrates safety and effectiveness of a novel 3-D vascular stent system in the femoropopliteal arteries of patients with symptomatic peripheral artery disease.

Timothy M. Sullivan, MD, FACS, FSVS, FSVM, FACC, chair of vascular and endovascular surgery Minneapolis Heart Institute and clinical professor of surgery at the University of Minnesota, announced that both the primary safety and effectiveness endpoints of the MIMICS-2 trial of the BioMimics 3D Vascular Stent System (Veryan Medical) were met. The rate of freedom from major adverse events at 30 days, defined as a composite of death, major amputation or clinically driven TLR, was 99.6% (95% CI, 97.7-100). The Kaplan-Meier estimate of freedom from loss of primary patency at 12 months was 81.9% at 1 year and the Kaplan-Meier estimate of freedom from clinically driven TLR at 12 months was 88.4%.

In addition, there were no stent fractures.

The MIMICS-2 Investigational Device Exemption (IDE) study was a prospective, single-arm, multicenter clinical study designed to evaluate safety and effectiveness of the 3-D stent for the treatment of patients with symptomatic atherosclerotic disease of the femoropopliteal artery (mean age, 68 years; 66% men). In total, 271 patients undergoing femoropopliteal interventions across 43 investigational sites in the United States (n = 162), Germany (n = 78) and Japan (n = 31) were enrolled.

At baseline, most patients presented with a Rutherford category of 3. Patients had traditional risk factors such as hypertension, hypercholesterolemia and current or former smoking, and Sullivan noted that this study included a higher percentage of patients with diabetes compared with other studies. The majority of lesions were in the mid- and distal superficial femoral artery. About half of patients had moderate to severe calcification.

The majority of patients received one stent, but 12% had two stents placed. The mean stented segment length was 112.3 mm.

Overall device and technical success were 100%.

These data were also presented at the Leipzig Interventional Course in January.

The BioMimics stent features a 3-D helical shape, designed to impart natural curvature to the diseased femoropopliteal artery, by promoting swirling flow and elevating wall shear. The helical shape is also designed to facilitate shortening of the stented segment during knee flexion and mitigate the risk for stented segment compression, according to a press release from Veryan.

“The unique BioMimics 3-D stent design provides hemodynamic and biomechanical benefits for both primary and complementary stenting,” Sullivan said.

The findings of this study “compare favorably with other studies [that] include drug-coated balloons or drug-eluting stents” in this challenging patient population, Sullivan said during the presentation.

Additionally, the new MIMICS-2 data confirm the results of a smaller randomized controlled trial of the 3-D stent vs. a straight stent.

“Natural swirling flow may be an alternative to antiproliferative drugs,” Sullivan said.

Evaluation of the 3-D stent continues in the MIMICS clinical program. To date, the stent has been evaluated in more than 1,250 participants at over 100 sites, according to Sullivan.

Veryan Medical announced on Feb. 1 that the company submitted a Premarket Approval (PMA) application for the 3-D stent to the FDA. – by Katie Kalvaitis

Reference:

Sullivan TM. Deep Dive Session 6: Abstracts and Late-breaking Sessions. Presented at: the International Symposium on Endovascular Therapy (ISET); Feb. 3-7, 2018; Hollywood, Fla.

Disclosure: Sullivan reports he is a consultant and principal investigator for Veryan; is an employee of Allina Health; is a meeting organizer for W.L. Gore and Associates; and is chair of a trial sponsored by C.R. Bard.

HOLLYWOOD, Fla. — One-year data from the MIMICS-2 trial demonstrates safety and effectiveness of a novel 3-D vascular stent system in the femoropopliteal arteries of patients with symptomatic peripheral artery disease.

Timothy M. Sullivan, MD, FACS, FSVS, FSVM, FACC, chair of vascular and endovascular surgery Minneapolis Heart Institute and clinical professor of surgery at the University of Minnesota, announced that both the primary safety and effectiveness endpoints of the MIMICS-2 trial of the BioMimics 3D Vascular Stent System (Veryan Medical) were met. The rate of freedom from major adverse events at 30 days, defined as a composite of death, major amputation or clinically driven TLR, was 99.6% (95% CI, 97.7-100). The Kaplan-Meier estimate of freedom from loss of primary patency at 12 months was 81.9% at 1 year and the Kaplan-Meier estimate of freedom from clinically driven TLR at 12 months was 88.4%.

In addition, there were no stent fractures.

The MIMICS-2 Investigational Device Exemption (IDE) study was a prospective, single-arm, multicenter clinical study designed to evaluate safety and effectiveness of the 3-D stent for the treatment of patients with symptomatic atherosclerotic disease of the femoropopliteal artery (mean age, 68 years; 66% men). In total, 271 patients undergoing femoropopliteal interventions across 43 investigational sites in the United States (n = 162), Germany (n = 78) and Japan (n = 31) were enrolled.

At baseline, most patients presented with a Rutherford category of 3. Patients had traditional risk factors such as hypertension, hypercholesterolemia and current or former smoking, and Sullivan noted that this study included a higher percentage of patients with diabetes compared with other studies. The majority of lesions were in the mid- and distal superficial femoral artery. About half of patients had moderate to severe calcification.

The majority of patients received one stent, but 12% had two stents placed. The mean stented segment length was 112.3 mm.

Overall device and technical success were 100%.

These data were also presented at the Leipzig Interventional Course in January.

The BioMimics stent features a 3-D helical shape, designed to impart natural curvature to the diseased femoropopliteal artery, by promoting swirling flow and elevating wall shear. The helical shape is also designed to facilitate shortening of the stented segment during knee flexion and mitigate the risk for stented segment compression, according to a press release from Veryan.

“The unique BioMimics 3-D stent design provides hemodynamic and biomechanical benefits for both primary and complementary stenting,” Sullivan said.

PAGE BREAK

The findings of this study “compare favorably with other studies [that] include drug-coated balloons or drug-eluting stents” in this challenging patient population, Sullivan said during the presentation.

Additionally, the new MIMICS-2 data confirm the results of a smaller randomized controlled trial of the 3-D stent vs. a straight stent.

“Natural swirling flow may be an alternative to antiproliferative drugs,” Sullivan said.

Evaluation of the 3-D stent continues in the MIMICS clinical program. To date, the stent has been evaluated in more than 1,250 participants at over 100 sites, according to Sullivan.

Veryan Medical announced on Feb. 1 that the company submitted a Premarket Approval (PMA) application for the 3-D stent to the FDA. – by Katie Kalvaitis

Reference:

Sullivan TM. Deep Dive Session 6: Abstracts and Late-breaking Sessions. Presented at: the International Symposium on Endovascular Therapy (ISET); Feb. 3-7, 2018; Hollywood, Fla.

Disclosure: Sullivan reports he is a consultant and principal investigator for Veryan; is an employee of Allina Health; is a meeting organizer for W.L. Gore and Associates; and is chair of a trial sponsored by C.R. Bard.

    See more from International Symposium on Endovascular Therapy