Boston Scientific has obtained CE Mark approval for its Agent Paclitaxel-coated PTCA balloon catheter, which provides physicians with an additional alternative to treat both in-stent restenosis (ISR) and de novo small vessel coronary disease.
The company has also announced the European market launch of the Agent drug-coated balloon (DCB) that combines the deliverability of the Boston Scientific Emerge balloon platform and paclitaxel.
The Agent DCB also incorporates TransPax coating technology that 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 Interventional Cardiology president Kevin Ballinger said: "Boston Scientific is committed to providing the best treatment options for patients with coronary artery disease.
"We believe the addition of a highly-differentiated DCB 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 US.