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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
Chatterjee S, Giri J. The Lariat for Left Atrial Appendage Closure: Rehash of Known Literature or a True Analysis?—Reply. JAMA Intern Med. 2015;175(11):1869-1870. doi:10.1001/jamainternmed.2015.5405