SOURCE: Kika Medical

KIKA Medical

April 10, 2009 11:40 ET

KIKA Clinical Solutions' EDC System for Clinical Asset Management Supports Terumo Corporation's Successful Enrollment of 3,000 Patients in Trial for Groundbreaking Nobori® Stent System

Landmark Trial Encompasses 129 Practice Centers in More Than 20 Countries on Three Continents

BOSTON, MA and PARIS--(Marketwire - April 10, 2009) - KIKA Clinical Solutions announced that Terumo Corporation is using KIKA's advanced EDC solution for clinical trial asset management on a 3,000-patient trial which is part of the NOBORI 2 study. KIKA is the top provider of advanced EDC solutions for clinical trials. Terumo is a global health care company dedicated to the research, development, manufacturing and marketing of products used in a wide range of medical applications.

NOBORI 2 is a prospective, multi-center, real-life study to validate the safety and effectiveness of the Nobori stent in 3,000 consecutive patients enrolled in routine daily practice in 129 centers across more than 20 countries and three continents. The primary endpoint is a device-oriented composite of cardiac death, myocardial infarction and target lesion revascularization at 12 months post-procedure.

The Nobori® stent system is a truly new-generation drug eluting stent with a bioresorbable polymer, offering best-in-class clinical results, excellent deliverability and a strong patient safety profile.

Dr Gian Battista Danzi with the Ospedale Maggiore Policlinico in Milan, Italy is the Principal Investigator of the NOBORI 2 study. Dr. Danzi said, "Particularly appealing is the expected quality of data from this trial with anticipated 100 percent online monitoring, onsite monitoring for the first 1000 patients and 30 percent of additional 2,000 patients, and all serious adverse events." He added that "the data collected from the 3,000 patients treated with the Nobori drug eluting stent in the large scale NOBORI 2 study will allow us to increase understanding about the efficacy and long term safety of this most innovative drug eluting stent, in a truly representative patient population." The KIKA EDC system allows online monitoring which is convenient for trial management personnel and increasing the quality of data.

KIKA CEO Linda Beneze said, "We are honored that such a large scale study as NOBORI 2 is utilizing KIKA's advanced EDC capabilities to manage critical data assets in this important clinical trial."

About Terumo

Terumo is a global health care company dedicated to the research, development, manufacturing and marketing of products used in a wide range of medical applications. Terumo has distinguished itself as a high quality manufacturer of medical products operating global production facilities and sales offices. The company generates annual sales surpassing $2.5 billion and employs 12 000 people worldwide. For more information, visit Nobori is a registered trademark of Terumo Corporation.

About KIKA Clinical Solutions

KIKA helps the world's most innovative biopharmaceutical and medical device organizations bring much-needed medical solutions to the market faster. KIKA's Clinical Asset Management platform provides unmatched flexibility and customization with advanced EDC including images and online adjudication. For more information, visit KIKA is a trademark of KIKA Clinical Solutions, Inc.

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