Abbott has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Xience Prime everolimus eluting coronary stent system, designed for treating coronary artery disease.
The stent system employs cobalt chromium technology and features a peak-to-valley mechanical design which imparts longitudinal strength and stability to the stent, while maintaining radial strength and visibility during stent implantation procedures.
The approval is backed by results from the Spirit Prime clinical trial, a prospective, two-arm, open-label, multicentre trial which assessed Xience Prime in approximately 500 patients with coronary artery disease.
In the study, the primary endpoint was target lesion failure (TLF) at one year, which was a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation.
The trial met its primary endpoint, demonstrating low rates of TLF, stent thrombosis rates at one year, with no cases of stent thrombosis reported in patients treated for long lesions. Xience Prime uses the same drug and biocompatible polymer as the Xience V everolimus eluting coronary stent system.
Teikyo University Hospital Division of Cardiology Dr. Takaaki Isshiki said new stent technologies such as Xience Prime play an important role in improving care for patients in Japan who have coronary artery disease.
"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," Isshiki added.
"Importantly, Xience Prime includes a broad size matrix and is the only everolimus eluting coronary stent in Japan with long-length stent sizes of 33mm and 38mm."
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.
Image: Xience Prime everolimus eluting coronary stent system from Abbott has been cleared in Japan. Photo: Frank C. Müller.