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March 5, 2012

Nobori stent reports safety, efficacy results in two year study

Japan-based Terumo's Nobori drug eluting stent (DES) has demonstrated efficacy and long-term safety in the two-year large Nobori 2 study when used in high risk unselected patients.

By admin-demo

STENT

Japan-based Terumo’s Nobori drug eluting stent (DES) has demonstrated efficacy and long-term safety in the two-year large Nobori 2 study when used in high risk unselected patients.

The Nobori DES stent system features a matrix of biodegradable, polymer polylactic acid (PLA) and the antiproliferative drug Biolimus A9 (Biosensors International), coated only alimentally on the stent platform.

Nobori 2 is a prospective open-label single arm multicentre study that enrolled 3,067 patients, with 53% having multivessel disease, 54% presenting in the course of acute coronary syndrome, 30% suffering from diabetes mellitus and more than 20% with lesions at bifurcation.

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 2 study results are consistent with previous trials of the Nobori clinical programme, confirming the safety and efficacy profiles of the stent both in simpler cases and in patients with high-risk clinical and anatomic features.

Principal investigator of the study Dr Gian Battista Danzi said the observed low rate of late and very late stent thrombosis in the study, which enrolled a highly complex patient population, adds evidence to the hypothesis that DES with biodegradable polymer may have better long term safety compared to the first generation of the devices.

Terumo Europe Interventional Systems president Toshi Osada said they are encouraged by the results of Nobori 2, as the ultimate goal of all Terumo technologies is to bring benefit to patients. Terumo Corporation develops, manufactures and distributes medical devices for use in cardiothoracic surgery, interventional procedures and transfusion medicine.

Image: The Nobori DES stent system from Terumo Corporation was found to benefit high risk patients. Photo: Frank C. Müller.

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