Boston Scientific (Boston) 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. The Promus Stent expands the company’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 FDA approval in 2008.
Promus is a 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 deliverability, a strong safety profile, low levels of late loss and improved efficacy, claims the company.
The stent is manufactured by Abbott and distributed by Boston under an agreement executed prior to the 2006 acquisition of Guidant by Boston. The Promus and XIENCE V Stents are identical products sold by the respective companies under different brand names.
The company said that it will continue to market its internally developed paclitaxel-eluting Taxus Stent systems. 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 28mm long) with reference vessel diameter of 2.5 to 3.75mm.
Maulik Nanavaty, president of Boston Scientific Japan, said: “We are pleased to receive MHLW approval for the PROMUS Stent in 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.”