The FlexStent femoropopliteal self expanding stent system is indicated for the treatment of peripheral vascular lesions involving the superficial femoral and popliteal arteries.
The fully connected flexible FlexStent has coupled technology with clinical needs by providing a stent with superior durability, flexibility, and radial stiffness, while providing uniform scaffolding, the company said.
In addition to the CE Mark, FSS plans to submit an investigational device exemption (IDE) application to the FDA. FDA IDE approval will allow FSS to commence a US clinical trial to collect clinical data for FDA pre-market approval.
Janet Burpee, CEO of FSS, said: “This is a significant milestone for FSS. We have been working diligently in preparation for CE Mark on this system. We believe our platform technology will provide needed clinical solutions in the interventional radiology, cardiology and gastroenterology device marketplace.”