Abbott Vascular Receives FDA Approval for Xience Prime DES

November 1, 2011—Abbott Vascular (Santa Clara, CA) announced that it has received US Food and Drug Administration (FDA) approval for the next-generation Xience Prime everolimus-eluting coronary stent system for the treatment of coronary artery disease.

According to the company, Xience Prime uses the same drug and biocompatible polymer as the Xience V everolimus-eluting coronary stent system, and it features an enhanced stent design and a delivery system that is designed to provide flexibility, radial strength, longitudinal strength, and more accurate stent placement. 

Abbott Vascular stated that the Xience Prime is based on the stent design of the company's Multi-Link family. It utilizes cobalt chromium technology and features a peak-to-valley mechanical design that imparts longitudinal strength and stability to the stent. In addition, Xience Prime features thin struts, maintains radial strength to support the vessel, and provides visibility under x-ray during stent implantation procedures. It is offered in long lengths of up to 38 mm.



The company noted that FDA approval of Xience Prime was supported by results from the prospective SPIRIT PRIME open-label clinical trial that evaluated the device in 500 patients with coronary artery disease. The trial met its primary endpoint with low rates of target lesion failure at 1 year. Stent thrombosis rates at 1 year also were low.

SPIRIT PRIME was conducted at more than 60 centers in the Unites States and Australia. Two registry arms were evaluated: the core size arm and the long lesion arm. The core size arm used Xience Prime stents with 2.25- to 4-mm diameters and 8- to 28-mm lengths. The long lesion arm used Xience Prime stents with 2.5- to 4-mm diameters and 33- or 38-mm lengths. The primary endpoint was target lesion failure at 1 year, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization.

Marco Costa, MD, Principal Investigator of the global SPIRIT PRIME trial, will present the full results on November 8 at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.


“Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease,” commented Dr. Costa. “With Xience Prime, for the first time in the United States, physicians have a 38-mm everolimus-eluting stent for the treatment of long lesions. The enhanced deliverability and wide range of sizes, including a small-vessel 2.25-mm diameter stent, will improve our ability to access challenging, complex lesions and thereby improve care for our patients.”