www.fdanews.com/articles/177945-spectranetics-earns-ce-mark-for-angiosculptx-drug-coated-catheter
Spectranetics Earns CE Mark for AngioSculptX Drug-coated Catheter
August 11, 2016
Spectranetics has attained CE Mark approval in the EU for its AngioSculptX drug-coated balloon catheter designed to treat coronary artery stenosis.
The device also was granted indications for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restinosis, the company said.
It is meant to be used in percutaneous transluminal coronary angioplasty procedures. — Cynthia Jessup