Atritech will have to conduct another study of its Watchman left atrial appendage closure technology before the FDA will grant it approval, the devicemaker reveals in a statement.
The Watchman is a permanent device inserted in a patient's left atrial appendage and is designed to keep harmful-sized blood clots that form in the left atrial appendage from entering the blood stream, potentially causing a stroke.
Last year, an FDA expert committee voted 7-5 in favor of approving the device. Panelists stipulated that the device only be implanted in centers with surgical backup, and that the company do long-term follow up with those who received the device in trials. The FDA's letter asks that a confirmatory study be conducted to affirm the safety and effectiveness of the Watchman. Atritech hopes to start that study later this year.
"The adoption of the Watchman technology in markets outside of the US has been largely due to the compelling data contained in the PROTECT AF clinical trial. The initiation of a confirmatory study combined with the continued follow up of our study patients will further establish the clinical significance of this important technology," says Jim Bullock, president and CEO of Atritech.
- here's Atritech's release