Abbott's just-announced acquisition of ablation catheter player Kalila Medical reflects the growing adoption of interventional electrophysiology and other devices to treat atrial fibrillation and stroke.
After disclosing a major restructuring of its medical device business last week, Johnson & Johnson tried to refocus on the future of that group on its annual earnings call. It emphasized doing more deals to acquire platforms for growth, as well as funneling more resources to high revenue growth device groups.
The Scripps Translational Science Institute (STSI) has launched a study of up to 6,100 patients using a wearable patch for continuous cardiovascular monitoring that's intended to identify asymptomatic atrial fibrillation (AFib) patients. A type of heart arrhythmia, AFib raises stroke risk by roughly fivefold and is associated with other health complications.
AtriCure said it will buy startup nContact as well as narrow its 2015 revenue guidance to the high end of a previously disclosed range. The public cardiac player, which is focused on atrial fibrillation and left atrial appendage management, will purchase the cardiac ablation company for $8 million in upfront cash, 3.7 million in AtriCure shares and up to $50 million in additional regulatory milestones.
Good news for partners Bristol-Myers Squibb and Pfizer: In a Phase IV study of their new-age anticoagulant, Eliquis, atrial fibrillation patients posted adherence rates near 90%. And the icing on the cake? The company didn't need to shell out on patient education to get them there.
The U.S. Food and Drug Administration issued an alert that patient deaths and other serious adverse events have occurred due to the off-label use of the Lariat Suture Delivery Device marketed by startup SentreHeart. It's approved to deliver sutures for soft tissue closure, but surgeons have been using it to close the left atrial appendage in order to prevent stroke in patients with irregular heart rhythm.
Physicians conducted a systematic review of database reports of the outcomes associated with the off-label use of the Lariat device to prevent stroke in patients with atrial fibrillation. They found several instances of deaths and follow-up emergency surgery, which prompted the researchers to call for an evaluation of the device by the FDA in this indication and to question the safety of the 510(k) clearance process itself.
Medtronic announced that enrollment is underway on an atrial fibrillation trial involving a trio of its devices: the Arctic Front Advance Cryoballoon for ablating heart tissue, Symplicity Spyral Catheter for delivering renal denervation to fight high cholesterol, and Reveal Linq insertable cardiac monitor.
Medtronic said it has begun enrollment in a European clinical trial of its atrial fibrillation device as part of its efforts to eventually gain FDA approval for its Phased RF technology, which would be a first-of-its-kind system.
In a win for cardiac ablation device makers like Johnson & Johnson's Biosense Webster and AtriCure, two studies presented at the American College of Cardiology's annual meeting in San Diego concluded that performing atrial fibrillation ablation improves outcomes.