FDA News

Vascular stent system garners FDA approval

Veryan Medical announced that its vascular stent designed to mimic the shape of the femoropopliteal artery received FDA approval.

The device (BioMimics 3D, Veryan Medical) is indicated for treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery, according to a press release from the company.

Approval was based on results from the MIMICS-2 study, in which, as Cardiology Today’s Intervention previously reported, nearly all of the 271 patients enrolled were free from major adverse events at 30 days, and there were high rates of freedom from loss of primary patency and freedom from clinically driven target lesion revascularization at 1 year.

The stent has a 3D helical shape that imparts natural curvature to the culprit artery, which promotes swirling flow and elevates wall shear, resulting in protection of the endothelium, according to the release.

“The compelling MIMICS-2 results reinforce those from our earlier Mimics randomized clinical trial, and the combined results support our belief that BioMimics 3D stands to become a first-choice nitinol stent for both primary and complementary stenting in the femoropopliteal artery,” Chas Taylor, CEO of Veryan Medical, said in the release.

Disclosure: Taylor is an employee of Veryan Medical.

Veryan Medical announced that its vascular stent designed to mimic the shape of the femoropopliteal artery received FDA approval.

The device (BioMimics 3D, Veryan Medical) is indicated for treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery, according to a press release from the company.

Approval was based on results from the MIMICS-2 study, in which, as Cardiology Today’s Intervention previously reported, nearly all of the 271 patients enrolled were free from major adverse events at 30 days, and there were high rates of freedom from loss of primary patency and freedom from clinically driven target lesion revascularization at 1 year.

The stent has a 3D helical shape that imparts natural curvature to the culprit artery, which promotes swirling flow and elevates wall shear, resulting in protection of the endothelium, according to the release.

“The compelling MIMICS-2 results reinforce those from our earlier Mimics randomized clinical trial, and the combined results support our belief that BioMimics 3D stands to become a first-choice nitinol stent for both primary and complementary stenting in the femoropopliteal artery,” Chas Taylor, CEO of Veryan Medical, said in the release.

Disclosure: Taylor is an employee of Veryan Medical.