Biotronik initiates BIOWOMEN study

Wednesday, July 8, 2015

Biotronik, a manufacturer of cardio- and endovascular medical devices, has enrolled its frist patient in its BIOWOMEN clinical study. BIOWOMEN will investigate cardiac resynchronization therapy (CRT) response in women and men to evaluate if women respond better to treatment. It is the first study of its size to investigate the topic, addressing the urgent medical need for global, gender-specific clinical trials of heart failure (HF) patients.

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Biotronik announces first enrollments in new thromboembolic events study

Friday, January 16, 2015

Biotronik, a manufacturer of cardiovascular medical technology, has announced the first enrollments in its prospective, multi-center, international Reduce-TE Pilot study (Reduction of AF Ablation Induced Thrombo-Embolic Incidence). The study will assess the ability of the advanced irrigated ablation catheter AlCath Flux eXtra Gold to reduce the incidence of silent microemboli (SME). SME are a complication associated with catheter ablation of the pulmonary veins, a common treatment for atrial fibrillation (AF). The Biotronik ablation catheter features a GoldTip and a 3-D irrigation system which study investigators believe can diminish the number of SME via optimized cooling, thereby improving patient safety.

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FDA approves first ICD to be evaluated in clinical trials for use in MRIs

Friday, March 14, 2014

Biotronik, a manufacturer of cardiovascular medical devices, has announced that the FDA has approved the expansion of Biotronik’s ongoing ProMRI trial. The new phase of the trial (phase C) will study the company’s ProMRI technology in implantable cardioverter-defibrillator (ICD) devices. Biotronik is the only company in the world with an ICD that is approved for investigational use in an MRI (magnetic resonance imaging) scanner. The ongoing ProMRI study is the first step in making this standalone technology available in the U.S.

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