A next-generation heart stent designed especially for complicated medical procedures recently entered European and affiliated markets after receiving what's called a CE Mark.
Abbott's XIENCE Sierra gained the recognition, allowing the stent to be used throughout the European Union and other countries that recognize the CE Mark. The XIENCE Sierra is an advanced device that releases a substance that helps stop cell growth and keeps arteries clear.
With over four million Europeans succumbing annually to cardiovascular disease, Abbott welcomed the news and the approval’s potential impact on improving patients' quality of life.
"XIENCE Sierra can help cardiologists be even more precise when implanting the stent, which is important for efficacy and safety," said Dr. Charles Simonton, chief medical officer of Abbott's vascular business. "Its design, range of sizes and increased flexibility mean doctors don't have to use as much force when they implant a XIENCE Sierra stent compared to other stents."
The product boasts a superior safety record, according to Abbott. The XIENCE stent is coated with a special substance that reduces blood clot risk by interacting with blood proteins. It improves access to hard-to-reach lesions due to its streamlined design.
"Doctors tell us they need better tools to treat increasingly challenging cases, which involve multiple, or totally blocked arteries and complications such as diabetes," said Chuck Brynelsen, senior vice president of Abbott's vascular business. "We designed XIENCE Sierra with the goal of helping more people with coronary artery disease regain their health and return to their daily lives as quickly as possible."
More than eight million people have received XIENCE stents since it was first awarded a CE Mark in 2006, making it the most frequently used stent throughout Europe, according to the company.