Abbott has announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the Xience Xpedition everolimus-eluting coronary stent system for the treatment of coronary artery disease. According to a company release, Xience Xpedition’s enhanced deliverability, combined with the broadest size matrix in the Japanese market (including a 3.25mm diameter) will help physicians in Japan address a wide range of patients with coronary artery disease.
“The deliverability with Xience Xpedition is impressive, helping physicians navigate with ease through complex blockages inside the heart vessels,” said Masahisa Yamane, director, Cardiovascular Division, Saitama Sekishinkai Hospital, Saitama, Japan. “This approval offers physicians an important new treatment option to address a growing health concern in Japan; we look forward to the positive impact of this product in Japanese patients with coronary heart disease.”
Xience Xpedition employs a specialised balloon that helps physicians open difficult-to-treat blockages and ensures the stent fits securely against the walls of the blood vessel once implanted. The catheter that carries the stent has a low-profile design that allows it to move smoothly through the body and heart to the site of the blockage. The stent design is based on Abbott’s multi-link pattern, which is proven to impart strength and stability to the stent, according to the company.
In the company release it was stated that the Xience Xpedition is supported by robust clinical evidence from the Xience family of drug-eluting stents, including data from more than 53,000 patients across more than 100 studies, with long-term outcomes. The Xience family of stents has been extensively studied in Japanese patients, including five Abbott-sponsored trials involving more than 3,000 patients implanted with either Xience V or Xience Prime. In addition, several other studies, including investigator-initiated trials, have been conducted since the original launch in Japan of Xience V in 2010, making Abbott’s market-leading Xience family of stents one of the most studied drug-eluting stents in Japan.
Xience Xpedition is available in the USA, Europe, the Middle East and parts of Asia.
In the USA, the Xience Xpedition and Xience Prime stent systems, including Xience Prime LL, are indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease becasuse of de novo native coronary artery lesions (lesions ≤ 32mm) with reference vessel diameters of ≥2.25mm to ≤4.25mm.
In the USA, Xience V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease because of de novo native coronary artery lesions (lesions ≤28mm) with reference vessel diameters of 2.25mm to 4.25mm.