![]() |
![]() |
||||||||
|
|||||||||
TERUMO’S NOBORI™ DRUG ELUTING STENT SYSTEM CONTINUES TO SHOW EXCELLENT RESULTS October 23rd, 2007 Positive 9-months results of Terumo’s NOBORI 1, second phase clinical trial of Nobori™ Drug Eluting Stent (DES) system were presented today at Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington DC. Tokyo, Japan; Leuven, Belgium; Washington DC, USA; October, 22, 2007.
Positive 9-months results of Terumo’s NOBORI 1, second phase clinical
trial of Nobori™ Drug Eluting Stent (DES) system were presented
today at Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium
in Washington DC. Results of the trial, which was conducted in 29 centers
across Europe, Asia and Australia, demonstrated non-inferiority of the
Nobori™ stent system compared to Taxus® Liberte™ stent
system, with respect to the study’s primary endpoint of angiographic
in-stent late loss at 9-months (0.11±0.30 mm for Nobori™,
vs. 0.32±0.51 mm for Taxus® Liberte™, p<0.001). Major secondary endpoints showed superior results for the Nobori™ stent system including a significant reduction in angiographic binary restenosis rate and percent diameter stenosis at 9-months. Furthermore, the intravascular ultrasound findings favor Nobori™ with significantly lower in-stent volume obstruction. The 9-months Major Adverse Cardiac Events (MACE) rate for Nobori™ was 3.9-percent versus 5.6-percent for Taxus®. As defined in NOBORI 1 clinical trial the MACE rate includes cardiac death, heart attacks, and target vessel revascularization at 9-months. One of the most striking findings of this clinical trial is 0-percent Stent thrombosis rate for the Nobori™ stent versus 4.4-percent rate for the Taxus® Liberte™ stent. Stent thrombosis had been one of the gravest safety concerns for interventional cardiologists. "Besides already proven non-inferiority to the first generation Taxus® stent, the Nobori™ stent confirmed in this trial its non-inferiority and even superiority to the second generation Taxus® Liberte™ stent with respect to in-stent late loss. The continued positive results make the Nobori™ stent a promising treatment option for the patients with coronary artery disease", said Bernard Chevalier M.D. of the Centre Cardiologique du Nord, Paris, France, Principal Investigator of this study, who presented the trial results. "The absence of stent thrombosis in the Nobori™ stent and its exceptionally low restenosis rate are particularly appealing", added Dr. Chevalier. "These great clinical results, combined with the results of
other recently reported NOBORI trials reinforce our confidence in the
Nobori™ stent system and give us powerful scientific evidence for
successful launch of Nobori™ stent in Europe, upon regulatory approval"
said Hideo Arase, President & CEO Terumo Europe N.V.
"The outstanding results of NOBORI 1 trial with regards to efficacy,
but also to safety, with very low MACE and stent thrombosis rates, raises
our expectations that Nobori DES will make a substantial contribution
to the improvement of the outcomes for patients with coronary artery disease"
said Yutaro Shintaku, Group President, Cardiac & Vascular
Business, Terumo Corporation. About Nobori™ stent
Biolimus A9™ and technology of its elution from biodegradable polymer (poly-lactic acid) is a proprietary of Biosensors International with whom Terumo, in the year 2003, signed a licensing agreement for the development and marketing of drug eluting stent. Contact: Address: Web address: www.terumo-europe.com |
|||||||||