Biosensors International Group, a medical device company that specializes in developing, manufacturing and licensing technologies for use in interventional cardiology procedures and critical care, has announced a distribution agreement with Veryan Medical Ltd. for BioMimics 3D, a nitinol stent with unique three-dimensional helical geometry designed for use in the superficial femoral artery. The agreement covers certain international markets, but excludes the USA and Japan.
The BioMimics 3D stent incorporates Veryan’s patented 3D helical technology, an advanced stent design that promotes natural swirling blood flow to elevate wall shear stress, which has been shown to reduce neointimal hyperplasia. The 3D advanced design has also been shown to improve the biomechanical performance of the stent when implanted in the femoropopliteal artery, mitigating the risk of stent fracture and vessel kinking. An estimated 200,000 endovascular femoropopliteal procedures are performed each year in the EU alone.
Recently-presented two-year data from the Mimics study have confirmed that BioMimics 3D provides significant improvement in long-term patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention. The data indicate a correlation between primary patency and stent curvature. In addition, a 12-month Landmark analysis reinforces the longer term benefit of Veryan’s helical stent technology and shows a statistically significant improvement in the Kaplan-Meier estimate of survival from clinically-driven TLR through 24 months, compared to the control stent.
“We are delighted to have secured this important distribution agreement with Veryan for BioMimics 3D”, commented Biosensors International Group CEO Jose Calle. “This innovative device will complement our portfolio of products in the area of peripheral arterial disease”.
Veryan received CE Mark approval for the BioMimics 3D stent in September 2012. Biosensors expects to commence active promotion of BioMimics 3D in Q1 2015.