Abbott Gaines Japanese Approval for Coronary Stent System

The Ministry of Health, Labor and Welfare in Japan has approved Abbott Laboratories’ Xience Xpedition everolimus-eluting coronary stent system for the treatment of coronary artery disease (CAD), the most common form of heart disease. Xience Xpedition features a new delivery system designed to navigate smoothly through clogged blood vessels in the heart during an angioplasty procedure, particularly in patients with complicated heart vessel anatomy.

According to data from the World Health Organization, heart disease is one of the leading causes of death in Japan, accounting for nearly one-third of all deaths in the country. Xience Xpedition’s enhanced deliverability, combined with the broadest size matrix in the Japanese market, including a unique 3.25 mm diameter, will help physicians in Japan address a wide range of patients with CAD.

“The deliverability with Xience Xpedition is impressive, helping physicians navigate with ease through complex blockages inside the heart vessels,” said Masahisa Yamane, M.D., director of the Cardiovascular division at Saitama Sekishinkai Hospital in 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 specialized balloon designed to help 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.

Xience Xpedition is supported by 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, claims Abbott. 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.

“The approval of Xience Xpedition in Japan is a significant milestone in the global expansion of Abbott’s leading next-generation drug eluting stent system, continuing Abbott’s long history of stent innovation for the benefit of patients around the world,” said Chuck Foltz, senior vice president of Abbott’s vascular business. “With the growing prevalence of heart disease in Japan, Abbott is pleased to offer physicians an additional treatment option that is backed by the strong clinical outcomes and unique design advantages of the market-leading Xience family of drug eluting stents.”

Abbott is a medical device company located in Abbott Park just outside Chicago, Ill.