The recently published two-year data from the large NOBORI 2 study confirmed the excellent and sustained performance of the Nobori® drug eluting stent (DES) when used in high risk unselected patients.
NOBORI 2 is a prospective, openlabel, single arm, multi-centre study that enrolled 3067 patients with 5463 lesions in 125 centers in Europe and Asia who were treated with a Nobori DES(1). The complexity of the patient population enrolled in the study is fully representative of contemporary percutaneous coronary intervention practice with 53% of the patients having multi-vessel disease, 54% presenting in the course of acute coronary syndrome, 30% suffering from diabetes mellitus, and more than 20% with lesions at bifurcation. See table above.
The high compliance with follow-up at both one and two years in the NOBORI 2 study further reinforces the validity of the results.
"The observed low rate of late and very late stent thrombosis in this study that enrolled a highly complex patient population adds evidence to the hypothesis that DES with biodegradable polymer may have better long term safety as compared to the first generation of these devices," commented Dr. Gian Battista Danzi, Ospedale Maggiore, Milan Italy, the Principal Investigator of the study.
"We are very encouraged by the results of NOBORI 2 as the ultimate goal of all Terumo technologies is to bring benefit to patients", said Mr. Toshi Osada, President of Terumo Europe Interventional Systems.
The results of the NOBORI 2 study are in agreement with and complement previous trials of the comprehensive NOBORI clinical program providing proof of the very good safety and efficacy profiles of the stent both, in simpler cases and in patients with high-risk clinical and anatomic features.
For further information, please contact: Olivier Archer, General Manager Interventional Cardiology, Terumo Europe N.V., Tel: +33 1 39 30 47 53, Email: email@example.com or Dr. Dragica Paunovic, Chief Medical Officer, Terumo Europe N.V., Tel: +32 16 38 14 05, Email: firstname.lastname@example.org
(1) Danzi GB et al.: Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: the NOBORI 2 study. EuroIntervention 2012 Jan 26. pii: 20111230-03 [Epub ahead of print]
The Nobori® DES stent system has a unique design concept with a matrix of biodegradable, polymer polylactic acid (PLA) and the antiproliferative drug Biolimus A9™ (Biosensors International), coated only abluminally on the highly flexible stent platform. PLA polymer in the Nobori® DES system degrades primarily by hydrolysis and the degradation product, water-soluble lactic acid, is absorbed by tissue and is eventually converted to water and carbon dioxide. The precise drug release kinetic of the Nobori® stent matches the biological response to procedure-induced injury with a burst release immediately after stent implantation and continuous drug release along with polymer degradation to further prevent neointima growth. Nobori® is currently available in Europe, Latin America, Asia and Japan.
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with $4.0 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures, and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures, and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use.
Terumo contributes to society by providing valued products and services to the healthcare market and by responding to the needs of healthcare providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.