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.
iRhythm has received a CE mark in Europe for its continuous heart monitoring Zio Service. The technology enables up to 14 days of continuous heart monitoring via a wireless patch; it includes analytical software, as well as report to the physician. In addition, iRhythm has partnered with cardiology distributor CardioLogic to market Zio in the U.K. for the diagnosis of atrial fibrillation and other cardiac arrhythmias.
Boston Scientific has invested in Iowa Approach, a new startup devoted to its novel atrial fibrillation (AF) ablation technology. The technique is expected to be easier and cheaper than the current AF ablation procedures; there are about 400,000 ablations to treat AF annually. The company expects to be ready for testing in humans in 2016.