Veryan, a vascular device manufacturer based in the United Kingdom, received CE Mark Approval from the European Union for its new BioMimics 3D stent system. The BioMimics 3D stent is designed for the treatment of superficial proximal popliteal and femoral arteries in the leg. The system features a unique 3D design that mimics the natural shape found in a patient’s arteries.
Dr. Thomas Zeller is a principal investigator for Mimics at the Universal Heart Center. According to Dr. Zeller, the new stent architecture found in the Biomics 3D system will increase shear on an arterial wall by changing the movement pattern of blood in the circulatory system from a laminar flow to a swirling one. Increased arterial shearing stress has been shown in previous clinical studies to mitigate the risk of a patient developing neointimal hyperproliferation. In a prepared statement, Dr. Zeller said, "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 first unveiled clinical data for its new system at the 2012 Vascular InterVentional Advances conference. At the conference, the company was successfully able to show that all 50 of the patients enrolled in the Biomimetics 3D study were free from lesion revascularization and other complications following surgery. There were no amputations or deaths as a result of stent implantation.