CE Mark for Boston Scientific’s Agent™ Drug-Coated Coronary Balloon

Boston Scientific’s Agent™ Paclitaxel-Coated PTCA Balloon Catheter has gained CE mark approval and will now be launched in Europe.

Two weeks after announcing the CE marking of its Ranger peripheral vascular drug balloon, Boston Scientific now tells us its Agent™ Paclitaxel-Coated PTCA Balloon Catheter has gained European approval. The Agent Drug-Coated Balloon (DCB) provides physicians with an additional alternative to treat both in-stent restenosis (ISR) and de novo small vessel coronary disease.

Background

Boston Scientific’s Agent DCB combines the deliverability of the company’s Emerge™ balloon platform with the proven drug paclitaxel. It 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.

Company comments

“Boston Scientific is committed to providing the best treatment options for patients with coronary artery disease,” said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. “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.”

Source: Boston Scientific Corporation, PR Newswire

published: July 30, 2014 in: Approval/Clearance, Boston Scientific, Cardio

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