CE mark approval for Agent drug-coated balloon


Boston Scientific has received CE mark approval and begun the European market launch of the Agent paclitaxel-coated PTCA balloon catheter. The Agent drug-coated balloon provides physicians with an additional alternative to treat both in-stent restenosis and de novo small vessel coronary disease.

The Agent drug-coated balloon combines the deliverability of the Boston Scientific Emerge balloon platform and the proven drug paclitaxel. The Agent drug-coated balloon also features proprietary TransPax coating technology, which combines paclitaxel and a citrate ester excipient designed to maintain drug-coating integrity and maximize drug-transfer efficiency for consistent and predictable drug delivery.


“Boston Scientific is committed to providing the best treatment options for patients with coronary artery disease,” says Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. “We believe the addition of a highly-differentiated drug-coated balloon to our leading complex percutaneous coronary intervention portfolio strengthens the Boston Scientific position as a global innovator in interventional cardiology therapies.”


The Agent drug-coated balloon is not available for sale in the USA.