Medtronic Inc. won CE Mark approval in the European Union for its Captivia delivery system for the Valiant thoracic stent graft and said it will launch the system internationally.
The Minneapolis-based devices giant said it will begin selling the device, which is classed as an investigational device in the U.S. and is still undergoing clinical trials, in countries that recognize the CE Mark.
Stent grafts are fabric tubes with stents inside them, designed to seal blood vessels above and below a bulging aneurysm, channeling blood flow and relieving pressure on the weakened area. Medtronic said more than 15,000 patients worldwide have been implanted with the Valiant device in four years.