Boston Scientific Corporation has received CE Mark and begun the European market launch of the Agent Paclitaxel-Coated PTCA Balloon Catheter for innovative treatment options for coronary artery disease. 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.
The Agent DCB combines the deliverability of the Boston Scientific Emerge balloon platform and the proven drug paclitaxel. The Agent DCB also features proprietary TransPax coating technology, which combines paclitaxel and a citrate ester excipient designed to maintain drug-coating integrity and maximise 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," 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."
Coronary heart disease, also known as coronary artery disease, is a narrowing of the vessels that supply blood and oxygen to the heart. Recent statistics from the European Heart Network and the European Society of Cardiology show it is the single most common cause of death in Europe, accounting for 1.8 million deaths per year. Patients living with coronary heart disease may experience pain, shortness of breath and fatigue. They may also be at risk for a heart attack.
The Agent Drug-Coated Balloon is not available for sale in the US, a company press release said.