The approval is based on the results of a multi-center, open-label, prospective, two-arm Spirit Prime trial which assessed Xience Prime in approximately 500 patients with coronary artery disease.

The trial met its primary endpoint, with low rates of target lesion failure (TLF) at one year.

Stent thrombosis rates at one 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.

Teikyo University Hospital cardiology division Takaaki Isshiki samdbrid Xience Prime retains many of the features of Xience V and also includes improvements, which will enhance ability to access 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," Isshiki added.

Xience Prime utilizes cobalt chromium technology and features a’ peak-to-valley’ mechanical design that imparts longitudinal strength and stability to the stent.

Xience Prime helps in maintaining radial strength to support the vessel and also provide visibility under X-ray during stent implantation procedures.