Abbott's Xience Xpedition DES System Approved in Japan

July 10, 2013—Abbott Vascular (Santa Clara, CA) announced that Japan's Ministry of Health, Labor and Welfare has approved the company's Xience Xpedition everolimus-eluting coronary stent system for the treatment of coronary artery disease.

According to the company, the Xience Xpedition's specialized balloon helps open difficult-to-treat blockages and ensures that the stent fits securely against the walls of the blood vessel once implanted. A new low-profile catheter delivery system is designed for smooth navigations during angioplasty, particularly in patients with complicated coronary vessel anatomy. Xience Xpedition's enhanced deliverability is combined with a broad size matrix, which includes a 3.25-mm-diameter option. The foundation of the Xience Xpedition is Abbott Vascular's Multi-Link design, which features a pattern of three links per ring that is engineered to impart strength, support, and flexibility.

“The deliverability with Xience Xpedition is impressive, helping physicians navigate with ease through complex blockages inside the heart vessels,” commented Masahisa Yamane, MD, in the company's press release. Dr. Yamane is 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.”

Abbott Vascular stated that approval of the Xpedition is supported by the clinical evidence of the Xience family of drug-eluting stents, including five Abbott-sponsored trials involving more than 3,000 patients in Japan who were implanted with either the company's Xience V or Xience Prime. In addition, several other studies, including investigator-initiated trials, have been conducted since the original launch of the Xience V in Japan in 2010.

Abbott Vascular's Xience Xpedition is available in the United States, Europe, the Middle East, and parts of Asia. In the United States, the Xience Xpedition is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions that are 32 mm) with reference vessel diameters of > 2.25 mm to 4.25 mm, advised the company.