FDA clears Sulzer's IntraStent biliary endoprosthesis:
This article was originally published in Clinica
Sulzer IntraTherapeutics has received US FDA 510(k) clearance to market its IntraStent DoubleStrut Paramount XS (extra support) premounted stent delivery system for treating malignant biliary neoplasms. The balloon-expandable, stainless steel stent is premounted on Bard's Opti-Plast XT PTA balloon catheter and is available in a length of 17mm and diameters of 5-8mm, said the St Paul, Minnesota company. The device is designed for use with a 0.035" guidewire.