Updated Xience nets CE Mark, with shorter DAPT time
The Xience Xpedition Everolimus Eluting Coronary Stent System (Abbott) has received CE Mark in Europe for the treatment of coronary artery disease. The stent has indications to treat patients with complex disease such as diabetes, as well as an indication for a minimum duration of three months of dual anti-platelet therapy (DAPT).
Three months of DAPT is the shortest duration required for any major drug-eluting stent offered in Europe, according to Abbott, which added that long-term compliance to DAPT can be a challenge for patients and can lead to additional safety risks such as increased bleeding events.
The product will be offered with size matrices ranging from 2.25 mm to 4 mm, including a 3.25 mm diameter, and lengths from 8 mm to 38 mm. In the U.S., it remains an investigational device only and is not approved or available for sale.
The Abbott Park, Ill.-based company has launched the product in CE Mark countries.
Three months of DAPT is the shortest duration required for any major drug-eluting stent offered in Europe, according to Abbott, which added that long-term compliance to DAPT can be a challenge for patients and can lead to additional safety risks such as increased bleeding events.
The product will be offered with size matrices ranging from 2.25 mm to 4 mm, including a 3.25 mm diameter, and lengths from 8 mm to 38 mm. In the U.S., it remains an investigational device only and is not approved or available for sale.
The Abbott Park, Ill.-based company has launched the product in CE Mark countries.