CE Mark for Stent that Mimics the Shape of the Vascular System
Published date : 27 November 2012
Article date : 27 November 2012
Massdevice reports that UK medical device company, Veryan, has received CE Mark approval for the BioMimics 3D stent, designed to treat superficial femoral and proximal popliteal arteries of the leg. According to the manufacturer, the device features a 3-dimensional design which mimics the natural shape of the human vascular system and thereby reduces kinking, deformation and potential vessel trauma during leg flexion.
Apparently, the CE approval was based on Veryan's MIMICS study which compared the safety and efficacy of the BioMimics 3D stent with a standard nitinol stent in patients with peripheral artery disease, with follow-up at 6 and 12 months. They say that the data showed all 50 enrolled patients were free from clinically driven target lesion revascularisation when using BioMimics 3D stent. There were no deaths or amputations.
Source: Massdevice, 23 November 2012
Read the original article here.
