Abbott Vascular's Xience Prime DES Approved in Japan

April 9, 2012—Abbott Vascular (Santa Clara, CA) announced that it received approval from the Japanese Ministry of Health, Labor, and Welfare for the next-generation Xience Prime everolimus-eluting coronary stent system for the treatment of coronary artery disease.

In Japan, Xience Prime is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤ 32 mm) with reference vessel diameters of ≥ 2.5 mm to ≤ 3.75 mm. In the United States, Xience Prime is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25.

According to Abbott Vascular, Xience Prime, which is based on the stent design of the company's Multi-Link family, utilizes cobalt chromium technology and features a "peak-to-valley" mechanical design that imparts longitudinal strength and stability to the stent. The device features thin drug-eluting stent struts while maintaining radial strength to support the vessel, and providing visibility under X-ray during stent implantation procedures. Xience Prime is offered in lengths up to 38 mm to treat long lesions.

The company noted that approval of Xience Prime in Japan was supported by results from the SPIRIT PRIME clinical trial, a prospective, open-label trial that evaluated Xience Prime in approximately 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 very low (0.5%), with all cases occurring within 30 days and no cases of stent thrombosis reported in patients treated for long lesions.

Xience Prime received CE Mark in 2009 and US Food and Drug Administration approval in 2011. It is available in the United States, Europe, the Middle East, Japan, and several countries in the Asia-Pacific and Latin America regions.

"New stent technologies such as Xience Prime play an important role in enhancing the care we provide to patients in Japan who have coronary artery disease," commented Takaaki Isshiki, MD. "Xience Prime retains many of the features that have made Xience V an important treatment option for patients, and incorporates improvements that will enhance our ability to access challenging and complex lesions. Importantly, Xience Prime includes a broad size matrix and is the only everolimus eluting coronary stent in Japan with long-length stent sizes of 33 mm and 38 mm."