Latest Headlines

Latest Headlines

Biotronik wins CE mark for the first bioresorbable magnesium scaffold for CAD

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 wins FDA approval for insertable cardiac remote monitor

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.

UPDATED: Biotronik responds to ICD safety study with economic benefits of its 'MRI-safe' version

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.

Biotronik vascular stent determined effective in challenging cases of peripheral artery disease

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's investigational nitinol stent shows promise in clinical trials

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 completes Dreams bioresorbable stent trial enrollment after several delays

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.

Biotronik resolves kickback allegations in $4.9M settlement with feds

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.

Study: Heart rhythm telemetry implants improve patient outcomes

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.

Leaders emerge in the race for the first U.S. bioresorbable stent

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 scores FDA approval for MRI-safe pacemaker system

Biotronik scored FDA approval for its next-generation, MRI-safe pacemaker system, continuing its winning streak for its implantable cardiac devices.