This approval represents an important step forward for Abbott -- Japan is a major market for stents and Abbott's stent sales have dropped this past year, especially in the U.S. where its older XIENCE V (and twin PROMUS, marketed by Boston Scientific) had a virtual monopoly on the second-generation DES market, until Medtronic's Resolute Integrity was approved last February. Medtronic's stent, which has shown equivalence to Abbott's in virtually every major study, has taken significant market share from both Abbott and Boston Scientific.
Abbott is also in U.S. trials with its Absorb coronary scaffold: a bioresorbable stent that is currently approved in Europe.
Abbott Announces Approval of Next-Generation XIENCE Xpedition™ Drug Eluting Stent System in Japan
- Enhanced Deliverability with New Stent Delivery System
- Leverages Proven Clinical Outcomes of the XIENCE Family of Drug Eluting Stents
- Offers the Broadest Size Matrix in the Japanese Market, Including a Unique 3.25 mm Diameter for More Accurate Vessel Sizing
July 10, 2013 -- Abbott Park, Illinois -- Abbott today 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 (CAD), the most common form of heart disease. XIENCE Xpedition is supported by the robust clinical evidence of the XIENCE family of drug eluting stents and 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.
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, 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."
Multiple proprietary design features make XIENCE Xpedition a unique and effective option for treating blockages in vessels of the heart. XIENCE Xpedition employs a specialized 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 has a long heritage of successful stent design and is proven to impart strength and stability to the stent.
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.
"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, vascular, Abbott. "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."
About the XIENCE Family of Drug Eluting Stents
XIENCE Xpedition is available in the United States, Europe, the Middle East and parts of Asia. XIENCE PRIME and XIENCE V are available in countries throughout the world.
In the United States, 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 due to de novo native coronary artery lesions (lesions ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. Additional information about XIENCE Xpedition and XIENCE PRIME, including important safety information, is available at www.xiencestent.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/eIFU_Xience_Xpedition.pdf and http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/eIFU_XIENCE_PRIME_XIENCE_PRIME_LL.pdf
In the United States, XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm. Additional information about XIENCE V, including important safety information, is available at http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/eIFU_XIENCE_V_XIENCE_nano.pdf.
The unique MULTI-LINK stent design is the foundation of the following Abbott stents: MULTI-LINK VISION®, MULTI-LINK 8®, XIENCE V, XIENCE PRIME and, most recently, XIENCE Xpedition. A key feature of the MULTI-LINK pattern is three links per ring designed to impart strength and support while also offering flexibility. More than 12 million implants of Abbott products with the MULTI-LINK platform have occurred worldwide since 1995.
The XIENCE family of drug eluting stents delivers everolimus, an anti-proliferative drug used in Abbott's XIENCE coronary stent systems. Everolimus was developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent or scaffold implantation.
About Abbott Vascular
Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.
About Abbott
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.
