Vascular devices maker Veryan landed CE Mark approval for its BioMimics 3D stent, a device designed to treat superficial femoral and proximal popliteal arteries of the leg.
The BioMimics 3D stent, which features a 3-dimensional design, can mimic the natural shape of the human vascular system to reduce kinking, deformation, and consequential vessel trauma during leg flexion, according to a press release.
The approval was based on the Veryan’s MIMICS study, which compared the safety and efficacy of the BioMimics 3D stent with a standard nitinol stent in patients with peripheral artery disease, with follow-up at 6 and 12 months.
“Besides reducing the risk of stent fracture, the unique BioMimics 3D stent architecture has been shown in preclinical animal studies to transform a laminar flow into a swirling flow, a phenomenon known to increase wall shear stress, which may mitigate the development of neointimal hyperproliferation,” Dr. Thomas Zeller, Mimics principal investigator at University Heart Centre said in prepared remarks. “The 6-month results of the trial have proven the safety of the new stent design, and we are eagerly awaiting the 12-month patency results where we expect at least a positive performance signal.”
The company in October unveiled the interim mimics data at 2012 Vascular InterVentional Advances meeting, which showed all 50 enrolled patients were free from clinically driven target lesion revascularization when using BioMimics 3D stent, and there were no deaths or amputations, Veryan said.