Veryan‘s helical BioMimics 3D stent met its primary safety and efficacy endpoints in a study of 271 patients with symptomatic femoropopliteal artery disease, according to TCTMD.
The device, which is shaped to mimic the natural geometry of human vasculature, compared favorably with drug-coated balloons and stents.
The probability of maintaining primary patency after 12 months was 81.9% for the BioMimics 3D device. The helical stent was beaten out by Cook Medical‘s Zilver PTX product, which had the highest probability at 82.7%, and Spectranetics‘ Stellarex device at 82.3%. Medtronic‘s (NYSE:MDT) In.Pact balloon had a 78.4% probability of maintaining primary patency after one year, followed by C.R. Bard‘s (NYSE:BCR) Lutonix device at 73.5%.
At the International Symposium on Endovascular Therapy, Dr. Timothy Sullivan reportedly explained that the curvature of the device promotes a swirling flow of blood, which increases wall shear stress and serves an “alternative to antiproliferative drugs.”
Veryan’s device won CE Mark approval in 2012 and the company is conducting clinical trials in the hopes of winning approval for the stent in the U.S., Germany and Japan.
The study, Mimics-2, found that patients who were treated with the device had a 99.6% rate of freedom from major adverse events through 30 days.
After one year, freedom from clinically-driven target lesion revascularization was 88.4%, according to TCTMD. Veryan plans to follow the patients enrolled in Mimics-2 for 36 months.