Boston Scientific just announced that it received the European CE Mark of approval for its Agent Paclitaxel-Coated PTCA Balloon Catheter. The device is intended to treat new small vessel narrowings as well as in-stent restenosis.
The device is essentially the company’s Emerge angioplasty balloon with a coating of paclitaxel and a citrate ester excipient, a material that helps to “maintain drug-coating integrity and maximize drug-transfer efficiency for consistent and predictable drug delivery,” according to the company. It’s still an investigational device in the U.S. and is not available for sale.
Press release: Boston Scientific Receives CE Mark For Agent™ Drug-Coated Balloon…