[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Views 255
Citations 0
Comment & Response
Less Is More
November 2015

The Lariat for Left Atrial Appendage Closure: Rehash of Known Literature or a True Analysis?—Reply

Author Affiliations
  • 1Division of Cardiology, St Luke’s-Roosevelt Hospital, Mount Sinai Health System, New York, New York
  • 2Cardiovascular Medicine Division, University of Pennsylvania Perelman School of Medicine, Philadelphia
JAMA Intern Med. 2015;175(11):1869-1870. doi:10.1001/jamainternmed.2015.5405

In Reply We thank Nagaraj et al for their interest and thoughtful commentary. We do not feel that the US Food and Drug Administration (FDA) was lax in their clearance of the Lariat (SentreHeart Inc) device as a 510(k) class II device. Rather, the organization appears to have been misinformed regarding the primary intended use of the device—closure of the left atrial appendage (LAA)—and unfortunately did not yet have a mechanism in place to track real-world usage of the device to discover this primary intended use. The FDA has set prior precedent that novel LAA closure devices are class III (ie, high-risk) devices and require full premarket approval supported by clinical data derived from investigational device exemption (IDE) trials.1

First Page Preview View Large
First page PDF preview
First page PDF preview