Biotronik received a CE Mark for its bioresorbable scaffold. The device, intended for the treatment of coronary artery disease without using a permanent implant, is the first clinically proven magnesium scaffold.
Biotronik scored FDA approval for its insertable cardiac remote monitor, giving the company a boost in a crowded market. Regulators signed off on Biotronik's BioMonitor 2, a subcutaneous device that helps doctors flag and diagnose heart conditions including atrial fibrillation, ventricular tachycardia and fibrillation, and strokes.
Germany's Biotronik announced the publication of a study in HeartRhythm that shows the MRI compatibility of its implantable cardioverter defibrillators, as it races with Medtronic to be the first to get an MRI-safe version of the cardiology device to market. The company said it has submitted the study to the FDA in support of the approval of the Iforia ProMRI ICD system.
Germany's Biotronik touted a recent study of its CE-marked Pulsar-18 stent for peripheral artery disease, saying the data showed the device can be used in challenging cases of the condition.
Biotronik said at the Cardiovascular Research Technologies conference that its investigational Astron self-expanding nitinol stent for the narrowing of the leg's iliac or external arteries met its clinical endpoint, as the company chases FDA approval.
Biotronik announced that the second clinical trial of its Dreams drug-eluting bioresorbable stent met another milestone as it races to become the third player in the emerging space. The Biosolve-II trial has completed enrollment, the company said. Its primary outcome measure is late lumen loss at 6 months, according to ClinicalTrials.gov.
Germany's Biotronik agreed to pay $4.9 million to the government to settle allegations that it paid kickbacks to doctors in Arizona and Nevada to persuade them to use its devices.
Patients implanted with heart rhythm devices that automatically send information about cardiac abnormalities to a telemonitoring center showed improved outcomes in heart failures and fewer deaths than those without the remote monitoring leads, according to a new study.
Most devices are launched in Europe before arriving in the U.S., and cardiology devices are certainly no exception to the rule. Tough FDA premarket review standards, and the novelty of the technology, have turned the race to sell the first bioresorbable stent in the U.S. into a marathon.
Biotronik scored FDA approval for its next-generation, MRI-safe pacemaker system, continuing its winning streak for its implantable cardiac devices.