Boston Scientific Corporation (NYSE: BSX) announced today that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its PROMUS® Everolimus-Eluting Coronary Stent System for the treatment of coronary artery disease. The Company plans to launch the product as soon as reimbursement approval is granted, which is expected in the coming weeks.
The PROMUS Stent expands Boston Scientific's drug-eluting stent (DES) portfolio in Japan, which also includes the TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System. The PROMUS Stent received CE Mark approval in 2006 and U.S. Food and Drug Administration approval in 2008.
Boston Scientific is the only company to offer physicians the choice of two different drugs (paclitaxel and everolimus) on separate DES platforms.
"The approval of the PROMUS Stent in Japan is welcome news for physicians and their patients with coronary artery disease," said Professor Masato Nakamura, Cardiovascular Internal Medicine, Cardiovascular Catheter Treatment Center, Toho University Medical Center in Tokyo. "The safety and efficacy of the PROMUS Stent have been well demonstrated in multiple clinical studies and years of real-world use. The advanced features of this stent make it a valuable addition to the DES treatment options available in Japan."
The PROMUS Stent is a next-generation, highly deliverable stent made from cobalt chromium, which allows for thinner struts without sacrificing strength or visibility. The combination of the polymer/stent platform and the controlled release of the everolimus drug is designed to provide excellent deliverability, a strong safety profile, low levels of late loss and improved efficacy.
"We are very pleased to receive MHLW approval for the PROMUS Stent in Japan," said Maulik Nanavaty, President of Boston Scientific Japan. "It complements our broad coronary intervention portfolio and reinforces our global leadership in the DES market. We remain committed to providing the most innovative products and therapies to the Japanese market."
The PROMUS Stent is a private-labeled XIENCE V® Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific under an agreement executed prior to the 2006 acquisition of the former Guidant Corporation by Boston Scientific. The PROMUS and XIENCE V Stents are identical products sold by the respective companies under different brand names.
Boston Scientific will continue to market its internally developed paclitaxel-eluting TAXUS Stent Systems. To date, more than six million TAXUS and PROMUS Stents have been implanted globally, making Boston Scientific the worldwide DES market leader.
The PROMUS (XIENCE V) Stent is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (up to 28 mm long) with reference vessel diameter of 2.5 to 3.75 mm.
Preventive PCI reduces cardiac event risks in patients with high-risk plaque