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.
The latest clinical trial results for Medtronic's insertable cardiac monitor show that it's effective at detecting atrial fibrillation at an even higher rate than found in a previous study. That could help the company make its case for reimbursement for the smallest cardiac monitor available, the Reveal Linq, which was launched early last year.
St. Jude Medical has won FDA approval for its FlexAbility Ablation Catheter. This is the first irrigated ablation catheter with a flexible tip to be available in the U.S. The technology is used by electrophysiologists in the treatment of cardiac arrhythmias.
AliveCor has reduced the price on its ECG monitor to $74.99 from $199; it's also now a third-generation device that is 50% thinner and 40% lighter.