login
Password reminder
Cardiovascular News
Contact the editor Visit Cardiovascular News Twitter feed Visit Cardiovascular News Facebook page
 

Xience Prime drug-eluting stent receives approval in Japan


Wednesday, 11 Apr 2012 11:35

Abbott has announced it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the next-generation Xience Prime Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. 


Approval of Xience Prime in Japan was supported by results from the SPIRIT PRIME clinical trial, a prospective, open-label trial that evaluated Xience Prime in approximately 500 patients with coronary artery disease. The trial met its primary endpoint, with low rates of target lesion failure at one year. Stent thrombosis rates at one year also were very low (0.5%), with all cases occurring within 30 days and no cases of stent thrombosis reported in patients treated for long lesions.

Xience Prime, which uses the same drug and biocompatible polymer as the Xience VEverolimus Eluting Coronary Stent System, features an enhanced stent design and a delivery system designed for greater flexibility, ideal radial strength, excellent longitudinal strength and more accurate stent placement. With this approval in Japan, Xience Prime is available in all of the major markets worldwide, including the United States, Europe, China, India and other countries in the Asia-Pacific and Latin America regions.


“New stent technologies such as Xience Prime play an important role in enhancing the care we provide to patients in Japan who have coronary artery disease,” said Takaaki Isshiki, Division of Cardiology, Teikyo University Hospital, Japan. “Xience Prime retains many of the features that have made Xience V an important treatment option for patients, and incorporates improvements that will enhance our ability to access challenging and complex lesions. Importantly, Xience Prime includes a broad size matrix and is the only everolimus eluting coronary stent in Japan with long-length stent sizes of 33 mm and 38 mm.”

Xience Prime is based on the stent design of the Multi-Link family. It utilises cobalt chromium technology and features a “peak-to-valley” mechanical design that imparts longitudinal strength and stability to the stent. Xience Prime features one of the thinnest drug-eluting stent struts available while maintaining radial strength to support the vessel, and it provides excellent visibility under X-ray during stent implantation procedures. It is offered in lengths up to 38 mm to treat long lesions.


About the SPIRIT PRIME clinical trial


The trial was conducted at more than 60 centres in the United States and Australia. Two registry arms were evaluated: the Core Size arm and the Long Lesion arm. The Core Size arm utilised Xience Prime stents measuring 2.25 mm to 4.0 mm in diameter and from 8 mm to 28 mm in length. The Long Lesion arm utilised Xience Prime stents measuring 2.5 mm to 4.0 mm in diameter and either 33 mm or 38 mm in length. The primary endpoint was target lesion failure at one year, which was a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation.


Xience Prime received CE mark in 2009 and US FDA approval in 2011, and is available in the United States, Europe, the Middle East, Japan and several countries in Asia-Pacific and Latin America.

In Japan, Xience Prime is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novonative coronary artery lesions (lesions ≤32 mm) with reference vessel diameters of ≥2.5 mm to ≤3.75 mm.




Add New Comment

Related Items


Most popular


Men believe “long working hours” stop women from being interventional cardiologists
Wednesday, 15 Jul 2015
According to a new survey published in EuroIntervention, men state that the long working hours and the need to be on call that is associated with being an interventional cardiologist are the key ... Men believe “long working hours” stop women from being interventional cardiologists

Boston Scientific launches bioresorbable scaffold trial
Monday, 20 Jul 2015
Boston Scientific has initiated a study to evaluate its fully resorbable scaffold technology. FAST (Fully absorbable scaffold feasibility study) is a prospective, single-arm study designed to assess ... Boston Scientific launches bioresorbable scaffold trial

Vascular Solutions introduces two new versions of Turnpike catheters
Thursday, 18 Jun 2015
All three versions of the Turnpike are over-the-wire catheters with an advanced shaft design that provides superior tracking and advancement over a 0.014” guidewire for use in complex coronary and ... Vascular Solutions introduces two new versions of Turnpike catheters

Features


Strut coverage: Optical coherence tomography and new stent technologies
Monday, 20 Jul 2015
Tim Kinnaird explores the risk of stent thrombosis with current technologies, how new technologies may be able to reduce this risk, and how OCT can help to assess this risk. Strut coverage: Optical coherence tomography and new stent technologies

The second generation of drug-eluting stents with biodegradable polymers may have potential advantages
Monday, 06 Jul 2015
Drug-eluting stents with biodegradable polymers have theoretical advantages over drug-eluting stents with permanent polymers—even second-generation drug-eluting stents. The second generation of drug-eluting stents with biodegradable polymers may have potential advantages

Profiles


Deepak L Bhatt
Tuesday, 09 Jun 2015
Deepak L Bhatt (Executive director of Interventional Cardiovascular Programs, Brigham and Women’s H... Deepak L Bhatt

Flavio Ribichini
Thursday, 05 Mar 2015
Flavio Ribichini speaks to Cardiovascular News about being involved in the first use of primary ... Flavio Ribichini

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions