US Food and Drug Administration officials have given the green light to Abbott's new drug-eluting stent designed to open blocked coronary arteries and restore blood flow.
The approval allows the XIENCE Xpedition Everolimus Eluting Coronary Stent System to immediately launch in the United States.
Direct stenting allows doctors to skip the first medical device and instead insert only the stent system.
The stent is unlike those previously approved in that it marks the first medication-coated stent approved for direct stenting. A traditional stent is threaded through a blood vessel after another device, such as a balloon catheter, first widens the clogged coronary artery.
In addition to requiring fewer medical devices, direct stenting also can save time in the operating room.
Samin K. Sharma, MD, director of Clinical and Interventional Cardiology, dean of International Clinical Affiliations, and president of the Mount Sinai Heart Network at Mount Sinai Medical Center, said the stent is well-suited to treat a wide range of patients because it combines powerful deliverability with a broad range of diameter sizes designed to fit a plethora of blood vessel sizes.
The widest diameter will be larger than that of any other stent already on the market. It also is available in varying lengths. This will allow cardiologists to more easily customize treatment, and provides additional options for patients with complex coronary anatomy.
The stent was approved after FDA officials reviewed data from more than 100 studies that included more than 45,000 patients. Patients were followed up to 5 years. Investigators found the stent to be safe and effective for treating coronary artery blockages.
The XIENCE Xpedition already is available in Europe, the Middle East and parts of Asia.