Biotronik said yesterday it launched its Ilivia magnetic resonance imaging-safe implantable cardioverter defibrillator in Japan. The Berlin-based company said the Ilivia device features both its ProMRI technology and its MRI AutoDetect feature which automatically recognizes when the user is in an MRI environment and switches to MRI mode. The device then switches back to normal functionality […]
Biotronik
Biotronik wins CE Mark for Edora MRI-adaptable pacers
Biotronik said today that it won CE Mark approval in the European Union for its Edora line of MRI-adaptable pacers. The German medical device company said the Edora pacemakers and cardiac resynchronization therapy pacemakers use a sensor called MRI AutoDetect that’s designed to ensure that the device goes into safe mode only during magnetic resonance scans, ensuring that […]
Biotronik launches its smallest MR-conditional pacing leads in US
Biotronik said today it launched its Solia S ProMRI 5.6 Fr magnetic resonance imaging conditional pacing leads in the U.S., touting them as the smallest available on the market. The newly launched leads, available in 45, 53 and 60 centimeter lengths, were approved last week based on data collected from the pre-market study phase of […]
Biotronik wins CE Mark for Magmaris bioresorbable scaffold
Biotronik said today it won CE Mark for its Magmaris magnesium bioresorbable scaffold designed to treat coronary artery disease. Data from the Biosolve-II trial of the stent was previously published in The Lancet, the company said, and 1-year data examining the safety of the device was recently published in The European Heart Journal. “Now that clinical results […]
Biotronik launches CardioMessenger Smart in U.S.
Biotronik said today it launched the CardioMessenger Smart portable cardiac pacing device monitor in the U.S. The CardioMessenger Smart is a portable device designed to allow pacemakers, implantable cardioverter defibrillators and insertable cardiac monitors to stay connected remotely to their monitoring physicians. “The clinical and economic benefits of remote monitoring have been well established over […]
EuroPCR 2016 Update: TAVR innovations, FFR systems in the spotlight
UPDATED May 20, 2016, with more results out of Paris. St. Jude Medical (NYSE:STJ) announced it won CE Mark approval in the European Union for its PressureWire X Guidewire fractional flow reserve measurement system and is launching the product in Europe. The company announced the launch and clearance at the EuroPCR meeting in Paris this week. […]
Biotronik launches Orsiro drug-eluting stent trial
Biotronik said today it enrolled the 1st patient in its BiostemI trial looking to compare the safety and efficacy of its Orsiro hybrid drug-eluting stent with Abbott‘s (NYSE:ABT) Xience Xpedition in treating ST-segment elevation myocardial infarction. The company is touting the trial as the largest investigator-initiated study pitting the Orsiro stent against the Xience Xpedition. The randomized, […]
Biotronik wins FDA nod for Iperia ProMRI HF-T defibrillator
Biotronik said today it won FDA premarket approval for its Iperia ProMRI HF-T cardiac resynchronization defibrillator, which is designed to be compatible with diagnostic magnetic resonance imaging scans. The Iperia line of devices also features remote monitoring with daily automatic transmission and closed loop stimulation designed to adapt heart rate in response to physiological demands, […]
Biotronik touts long-term Linox ICD lead data
Biotronik today released long-term data from registry studies of its Linox and Linoxsmart implantable cardioverter defibrillator leads, touting the survival probabilities of over 95% at 4 and 5 years. The company said its Galaxy and Celestial registry studies include data from a total of 3,933 Linox ICD leads implanted in 3,840 patients across 146 U.S. study […]
Biotronik wins FDA nod for BioMonitor 2
Biotronik said today it won FDA premarket approval for its BioMonitor 2 magnetic resonance imaging-compatible insertable cardiac remote monitor. The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and […]
Biotronik’s BioMonitor 2 hits U.K., Ireland
Biotronik said today it launched its BioMonitor 2 subcutaneous insertable cardiac monitor in the U.K. and Ireland. The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla […]