Healthcare Industry News: BIOTRONIK
News Release - February 25, 2011
Major Clinical Trial Investigates Intraoperative Defibrillator Testing While Using BIOTRONIK Home Monitoring(R) for Continuous Therapy SurveillanceNORDIC ICD study to randomize more than 580 cardiac-device patients and finally resolve this strongly debated issue
BERLIN--(Healthcare Sales & Marketing Network)-- BIOTRONIK SE & Co. KG announced today the start of the NORDIC ICD clinical trial. The first implantable cardioverter defibrillator (ICD) patients were enrolled by its coordinating clinical investigator, Prof. Dr. Dietmar Bänsch at the University Hospital of Rostock and the investigator Dr. Stefan Kuster at the DRK Hospital of Mölln/Ratzeburg.
“While it is has been commonly thought that intraoperative defibrillation testing is necessary to ensure adequate ICD and lead function it is also associated with infrequent, however serious adverse events such as death and stroke,” commented Dr. Johan Brandt, PhD, MD, from Skane University Hospital in Sweden. “Even though there is minimal data supporting routine intraoperative defibrillation testing, and no international guidelines that substantiate this practice, a clinical routine established decades ago is difficult to change. Trials such as NORDIC ICD are necessary to develop a solid evidence base that may alter clinical practice.” Dr. Brandt developed the study protocol with Prof. Bänsch. Both will oversee and control the study activities as coordinating clinical investigators.
NORDIC ICD is an international, multicenter, prospective, 1:1 randomized, controlled clinical study to evaluate whether ICD implantation without an intraoperative defibrillation (DF) test is noninferior to ICD implantation with intraoperative DF testing, regarding the long-term treatment efficacy of all spontaneous ventricular tachyarrhythmia episodes. The primary endpoint is the average efficacy of the first ICD shock for all true ventricular tachyarrhythmias of a patient in the observational period. More than 580 patients will be enrolled, primarily in Germany, Denmark, Sweden, Finland, Norway, Latvia and Czech Republic.
NORDIC ICD will be limited to the use of BIOTRONIK’s Lumax 540/340 ICD families and newer generations, with the capability of high energy defibrillation output. Patients will be continuously monitored using BIOTRONIK Home Monitoring® to ensure maximum safety. BIOTRONIK Home Monitoring® is the only remote patient management system with FDA and CE regulatory approvals for early detection—and is therefore ideal for up-to-the minute tracking of device and lead functioning and for collecting important device-based information regarding arrhythmias and changes in a patient’s clinical condition.
About BIOTRONIK SE & Co. KG
As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of over 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.
More information: www.BIOTRONIK.com
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