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KIKA Medical's Clinical Asset Management Software Vital to Biosensors Europe SA Pioneering Cardiac Stent Research

Posted on: Tuesday, 28 October 2008, 03:00 CDT

KIKA Medical announced that Biosensors International Group LTD relied on KIKA's advanced Web-based software platform for electronic clinical asset management on a landmark cardiac stent trial that could dramatically affect the care of coronary patients.

KIKA is a leading international provider of advanced electronic clinical trial solutions. KIKA's clinical asset management solution includes Veracity(TM), a Web-based software platform that offers an adaptive user interface and innovative database architecture; Professional Services; and a reliable and secure IT infrastructure. Biosensors develops, manufactures and markets innovative medical devices used in interventional cardiology and critical care procedures around the globe.

Biosensors Europe SA in Switzerland funded the study, which was under the supervision of Professor Stephan Windecker and Professor Patrick Serruys, the PI and co-PI of Leaders.

The study evaluated a novel biolimus-eluting stent with biodegradable polymer vs. a sirolimus-eluting stent with durable polymer for coronary revascularization (LEADERS) in a trial of more than 1,700 patients at 10 European centers.

Pedro Eerdmans, PhD., M.D., Director of Medical Affairs at Biosensors, said, "Working with KIKA Medical contributed greatly to the success of the LEADERS trial. Their solution enabled us to ensure fast enrollment, efficient data management and fast publication. We also found KIKA responsive and flexible."

The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularization within nine months. Analysis was by intention to treat. More than 425 patients were randomly allocated to angiographic follow-up, with in-stent percentage diameter stenosis as principal outcome measure at nine months.

Results show that a stent eluting biolimus from a biodegradable polymer represents a safe and effective alternative to a stent eluting sirolimus from a durable polymer in patients with chronic stable coronary artery disease or acute coronary syndromes.

Also participating in the study were the Bern University Hospital; Erasmus University in Rotterdam, Netherlands; Medical University of Silesia in Katowice, Poland; the Department of Cardiology, Hospital Bogenhausen in Munich, Germany; University Hospital in Munich; the Department of Cardiology in the University Hospital in Zurich, Switzerland; Institut Cardiovasculaire, Paris-Sud in France; and the Department of Cardiology in the Royal Brompton Hospital in London, UK.

Linda Beneze, CEO of KIKA, said, "Clinical trials are the genesis of driving change in healthcare. In late-stage trials especially, research and ideas are put to the test of whether they will make a meaningful difference in the health and safety of patients. KIKA was very pleased that an emerging industry leader like Biosensors entrusted us with their clinical assets in a groundbreaking trial that could significantly change cardiac care for thousands of patients."

The trial is registered with ClinicalTrials.gov, number NCT00389220. An article published in the Lancet's (www.lancet.com) online issue on September 1 of this year discusses the study in detail.

About KIKA Medical

KIKA helps the world's most innovative medical device and biopharmaceutical companies bring much-needed medical solutions to the market faster. The company's Clinical Asset Management platform offers a customized, three-part solution of advanced Web-based software, Professional Services and IT infrastructure. KIKA enables clients to implement and complete studies in the most efficient and cost-effective manner; protect and cultivate important relationships with investigators; and obtain the highest quality data. For more information visit www.kikamedical.com or call 1-617-619-9990 in the U.S.; +33 (0)1 53 17 95 70 in Europe; or email sales@kikamedical.com.

Forward-Looking Statements

Certain statements herein include forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements generally can be identified by the use of forward-looking terminology, such as "may,""will,""expect,""intend,""estimate,""anticipate,""believe,""project" or "continue" or the negative thereof or other similar words. All forward looking statements involve risks and uncertainties, including, but not limited to, customer acceptance and market share gains, competition from companies that have greater financial resources; introduction of new products into the marketplace by competitors; successful product development; dependence on significant customers; the ability to recruit and retain quality employees as Biosensors grows; and economic and political conditions globally. Actual results may differ materially from those discussed in, or implied by, the forward-looking statements. The forward-looking statements speak only as of the date of this release and Biosensors assumes no duty to update them to reflect new, changing or unanticipated events or circumstances.

KIKA, KIKA Medical and Veracity are among trademarks of KIKA Medical, Inc.

 Media contacts: For Biosensors Richard Kenyon Email Contact +44-7831-569-940  For KIKA Medical Brenda Nashawaty Email Contact 617-688-3253  

SOURCE: KIKA Medical

Source: MARKET WIRE

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