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


Drug-coated balloons are not inferior to drug-eluting stents for treating stent restenosis
Friday, 06 Mar 2015
A retrospective study indicates that drug-coated balloons are associated with similar angiographic and clinical outcomes to drug-eluting stents (including both first- and second-generation stents) ... Drug-coated balloons are not inferior to drug-eluting stents for treating stent restenosis

Thursday, 26 Feb 2015
Vitaria delivers autonomic regulation therapy for patients who have moderate to severe heart failure with left ventricular dysfunction (ejection fraction < 40%), and who remain symptomatic despite ... Vitaria vagal nerve stimulation system receives CE mark for treatment of chronic heart failure

Boston Scientific receives FDA approval for Watchman left atrial appendage closure device
Monday, 16 Mar 2015
The device offers an alternative to long-term warfarin therapy for stroke risk reduction in patients with non-valvular atrial fibrillation. Boston Scientific receives FDA approval for Watchman left atrial appendage closure device

Features


Robotic PCI could be used to reduce radiation exposure to the operator
Thursday, 09 Apr 2015
Ryan Madder, an interventional cardiologist at the Frederik Meijer Heart & Vascular Institute (Spectrum Health, Grand Rapids, Michigan, USA) explains why he believes a robotic system (CorPath, C... Robotic PCI could be used to reduce radiation exposure to the operator

SERVE-HF could be a wake-up call for cardiologists about central sleep apnoea
Tuesday, 24 Mar 2015
Martin Cowie (Imperial College London, London, UK) is the principal investigator of the SERVE-HF study, which is assessing the use of adaptive servo-ventilation (PaceWave, ResMed) in chronic heart ... SERVE-HF could be a wake-up call for cardiologists about central sleep apnoea

Profiles


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

Sunil Rao
Thursday, 23 Oct 2014
Sunil Rao speaks to Cardiovascular News about his career highlights, including his research into ... Sunil Rao

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