St. Jude Medical is hoping to strengthen its franchise in ablation catheters--thin, flexible wires inserted non-surgically into the heart to treat cardiac arrhythmia. Its FlexAbility irrigated ablation catheter has garnered a CE Mark in Europe, where it has marketed the TactiCath contact-force sensing irrigated ablation catheter since 2012. The company hopes to get FDA approval by year end for both FlexAbility and TactiCath.
Advanced Cardiac Therapeutics closed a new round of equity financing to support development of its innovative ablation catheter for atrial fibrillation.
Medtronic is looking make its device the first to be FDA-approved for long-running atrial fibrillation, shaking off a 2011 setback and kicking-starting enrollment in a new pivotal trial.
Topera Medical picked up FDA clearance for the latest generation of its 3-D Mapping System, a device designed to help diagnose cardiac arrhythmias without invasive surgery.
AtriCure is set to acquire California-based surgical ablation device maker Estech in a deal worth at least $34 million and almost double that amount down the line.
Daiichi Sankyo's atrial fibrillation-treating edoxaban posted promising results in Phase III, matching the stroke-prevention prowess of warfarin with a better safety profile, but the drug may struggle to carve out market share in a cluttered space.
Boston Scientific is ticking closer to judgment day for its much-scrutinized Watchman device, securing an FDA advisory hearing for a stroke-fighting implant that has faced doubts throughout its development.
Patients with atrial fibrillation, a common cardiac arrhythmia, are often at a heightened risk for stroke and other health problems. But researchers in the U.K. and elsewhere believe they have identified a biomarker that can help screen for folks who face a greater likelihood of complications.
Heart failure patients treated with a Medtronic defibrillator were roughly half as likely to endure atrial fibrillation than were those using other devices, according to a study.
After a three-year legal spat, Gore has prevailed over St. Jude Medical and can keep its heart plug on the market, the company said.