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Biotronik commences new ICD trial
Biotronik has commenced a clinical study that will aim to gauge the most effective approach when using implantable cardioverter defibrillators (ICD) to combat ventricular tachyarrhythmia.
The Nordic ICD trial will involve the company's Lumax 540/340 ICD families and will test whether ICD implantation without an intraoperative defibrillation (DF) test is non-inferior to implantation with intraoperative DF testing.
Biotronik's CE-Marked Home Monitoring system will also be utilised in the study to guarantee maximum patient safety.
It is hoped that Nordic ICD can resolve a long-debated issue in the medical community relating to the best and safest methods of conducting ICD implantations.
Professor Dr Dietmar Bansch at the University Hospital of Rostock, the trial's coordinating clinical investigator, said: "The major question remains as to whether we can optimise the clinical routine of this procedure and increase access to its life-saving therapy."
Earlier this month, Biotronik was granted CE Mark approval for Reliaty, its new pacing system analyser device, ahead of the product's European launch.
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