Biotronik said today it enrolled the 1st patient in its B3 trial examining the company’s Closed Loop Stimulation physiologic rate response sensor and algorithm. The study aims to whether pacemakers and implantable cardioverter-defibrillators equipped with the CLS sensor and algorithm are able to reduce the rate of stroke and improve outcomes in patients with atrial […]
Biotronik
Biotronik touts combo treatment of DCB and stent
Biotronik today said 2-year results from a trial studying the novel use of both drug-coated balloon and self-expanding stents to treat peripheral artery disease showed a high rate of primary patency sustained over the 24 months. Data from the trial was presented at the VEITHsymposium in New York City this week. Biotronik’s Passeo-18 Lux drug-coated balloons […]
TCT 2015: First-in-human results for Biotronik’s Dreams 2G absorbable stent
UPDATED Oct. 13, 2015 with expanded comments from Biotronik. Early data on a fully bioabsorbable metal stent, the Dreams 2G made by Biotronik, showed that the device performed better and was just as safe as older iterations of the technology, researchers said today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco. The Dreams 2G […]
Biotronik launches China arm in Orsiro stent trial
Biotronik said today it enrolled the 1st patient in its new Chinese Bioflow-VI study of its Orsiro drug-eluting stent for treating patients with coronary artery disease. The prospective, multi-center trial is slated to enroll 440 patients at 15 sites in China to support Chinese market approval of the Orsiro drug-eluting stent. “Based on the wealth […]
Biotronik wins CE Mark for BioMonitor 2
Biotronik said yesterday it won CE Mark approval in the European Union for its BioMonitor 2 subcutaneous insertable cardiac monitor and released results of a pilot study of the device. The device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The Australian pilot study reported an average […]
Biotronik launches 2 new studies
Biotronik announced 2 new studies last week that are slated to examine the company’s CRT-D device and BioMonitor implanted cardiac monitor. A 277-patient BioContinue clinical trial will examine the risk of ventricular arrhythmias after CRT-D replacement, enrolling patients over 2 years at 40 centers across 8 countries, the company said. Biotronik said the trial will […]
Biotronik wins CE Mark for new MRI-safe pacemakers
Biotronik said yesterday it won CE Mark approval in the European Union for 2 next-generation MRI-safe pacemakers. The new devices are compatible with up to 3 tesla MRI scanning machines, the company said. Around 20-30% of MRI machines worldwide are 3T machines, Biotronik said, and the number of these devices is growing. “The benefits of 3 […]
Biotronik wins FDA nod, launches Itrevia CRT-D in US
Biotronik said today it won FDA premarket approval for its quadripolar Itrevia HF-T cardiac resynchronization defibrillator and launched the device in the U.S. market. The device includes a closed loop stimulation algorithm, capable of adapting heart rate in response to physiological demands independent of movement or respiration, Biotronik said. “The FDA has approved CLS as […]
Biotronik launches CRT in women study
Biotronik said last week it enrolled the 1st patient in its Biowomen study investigating the difference in cardiac resynchronization therapy response in men and women to understand if women respond better to the treatment. The trial seeks to enroll 247 patients of each gender over 2 years, with a 1-year follow-up and results expected in 2018, the […]
Biotronik launches Itrevia MRI-safe quad CRT-D in Japan
Biotronik said today that it launched its Itrevia MRI-safe quad cardiac resynchronization therapy defibrillator in Japan, part of a Japanese rollout of new devices for 2015. The device is equipped with home monitoring connectivity, as well as compatibility with up to 1.5 tesla MRI machines, the German medical device giant said. “As a producer of superior […]
Biotronik launches U.S. study of Orsiro hybrid stent
Biotronik said it launched a U.S. investigational device exemption trial of its Orsiro hybrid drug-eluting stent, the Bioflow-V study. The Orsiro device’s coating includes 2 components, according to Biotronik: a passive element called ProBio designed to encapsulate the stent to minimize interaction between it and surrounding tissue, and an active combination of a limus anti-restenosis drug […]