AtriClip Stroke Safety and Feasibility Trial Gains FDA Approval

Cardiology company AtriCure has received U.S. Food and Drug Administration approval for a stroke safety and feasibility trial of its AtriClip device. The trial will enroll up to 30 patients at six sites and begin enrollment in the second half of 2012, CEO Dave Drachman said in a conference call with analysts.

The Cincinnati-area company is hoping to obtain FDA clearance to indicate its device for use in standalone procedures that involve exclusion of the left atrial appendage, a thumb-sized pouch on top of the left side of the heart from which blood clots that cause strokes often originate. AtriCure’s intentions were first noted on medlatest in December 2011, which can be found here.

Source: AtriCure