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.
Germany's Biotronik said it gained a new CE mark for a bipolar cardiac resynchronization therapy lead that is super-small and MRI-safe.
German devicemaker Biotronik launched its Passeo-18 Lux drug-releasing balloon in Europe, backed by stellar results.
Germany's Biotronik has treated its first patient in a multi-center trial of its bioabsorbable vascular scaffold, a study aimed at winning a CE mark for the coronary artery disease-treating device.