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.
A few weeks after the FDA allowed Biotronik to expand its ProMRI trial to implantable cardioverter-defibrillators, the company hasn't wasted any time moving ahead. The German cardiac device company said it performed initial ICD surgeries for the study at hospitals in Connecticut, Pennsylvania, North Carolina, Michigan, Virginia, New York and Oregon, generally involving its Iforia devices.
Biotronik has a CE mark in hand for its new Eluna pacemakers, made with MRI-compatible technology and other advances designed to help them stand out in an already-crowded, stagnant market.
The FDA will allow Biotronik to expand its ProMRI trial in the U.S. to implantable cardioverter-defibrillators (ICD), making the German device maker first to the starting line to test whether a patient with an ICD can safely undergo a magnetic resonance imaging (MRI) scan.
Germany's Biotronik said 6-month results from a broader study of a drug-coated balloon to treat leg blood clots showed a major boost in the standard of care compared to standard balloon angioplasty.