Two-Year Data Presented for Veryan's BioMimics 3D Nitinol Stent

November 4, 2014—Veryan Medical Ltd announced that 2-year data from the MIMICS study were presented during the late-breaking clinical trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada. Principal Investigator Professor Thomas Zeller, MD, of Universitäts-Herzzentrum in Freiburg-Bad Krozingen, Germany, presented the MIMICS data.

According to the company, the MIMICS data confirm that the company’s BioMimics 3D nitinol stent, which features three-dimensional helical curvature, provides a significant improvement in long-term primary patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention.

In addition to reinforcing the longer-term benefit of Veryan’s helical stent technology, the new 12-month landmark analysis presented at VIVA 2014 showed a statistically significant improvement in the Kaplan-Meier estimate of survival from clinically driven target lesion revascularization (TLR) through 24 months, compared to the control stent (P < .05).

The MIMICS study is a prospective, randomized, multicenter controlled trial conducted at eight German investigational centers and supported by an independent core lab. The trial enrolled 76 patients who were randomized 2:1 (50 BioMimics 3D vs 26 control) in patients undergoing femoropopliteal artery intervention. The MIMICS investigators compared the safety, efficacy and vascular hemodynamics of the BioMimics 3D stent to straight nitinol stents (24 of the 26 control patients were treated with CR Bard’s LifeStent).

The Kaplan-Meier survival estimate of freedom from loss of primary patency at 2 years was 72% for BioMimics 3D patients versus 55% for the control arm. The difference in survival estimate between the two groups by log rank test was significant (P < .05). Importantly, there was no increase in the Kaplan-Meier estimate of clinically driven target lesion revascularization rate in the BioMimics arm between 12 and 24 months (9% at both time points) compared to a three-fold increase (8% at 12 months and 24% at 24 months) in the straight stent control arm.

An improvement of one or more Rutherford categories was observed in 87% of BioMimics 3D patients at 24-months compared to baseline. A core lab review of straight and flexed knee x-rays did not detect any stent fractures in any BioMimics 3D stent. Biplanar x-ray imaging data indicate the ability of the femoropopliteal artery to adopt the three-dimensional curvature of the BioMimics 3D stent and computational fluid dynamic modeling provides evidence of secondary flow within the stented segment and predicts zones of elevated wall shear stress.

The company noted that MIMICS study data indicate a correlation between primary patency and stent curvature. BioMimics 3D stented segments showed significantly greater curvature (P = .02) compared with the control, providing swirling blood flow and elevated wall shear, which may explain the longer term patency protective effect seen with BioMimics 3D.

Across all patients, stent curvature was greater for BioMimics 3D stents compared to the straight control stents and no loss of patency was observed in patients with mean straight leg stent curvature above 0.02 mm^-1.

In the company’s press release, Professor Zeller commented, “These data suggest the existence of a patency protective effect provided by the biomimetic characteristics of the BioMimics 3D nitinol stent resulting in hemodynamic and biomechanical performance advantages over straight nitinol stents.”

According to Veryan Medical, the BioMimics 3D stent’s helical centerline geometry mimics natural vascular curvature that promotes secondary flow and elevated hemodynamic shear stress, which has a protective effect on the endothelium. The helical geometry of the BioMimics 3D femoropopliteal stent is also designed to enable coil-spring shortening of the stented segment during knee flexion and mitigate the risk of stented segment compression causing localized strains in a straight stent that may lead to stent fracture and chronic vascular injury.

Veryan stated that the BioMimics 3D stent received European CE Mark approval and the company is planning commercialization through an international distributor starting in the first quarter of 2015.