This article was originally published in The Gray Sheet
Investigational device exemption supplement is submitted to expand studies of the surgical adhesive to include use in vascular and certain cardiac repairs in addition to the commercially approved use as an adjunct in acute thoracic aortic dissections, cited in the original June 1998 IDE. A December FDA Humanitarian Device Exemption approval covers the latter indication, and shipments commenced Jan. 3 (1"The Gray Sheet" Dec. 20, p. 24)
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Surgical adhesive is granted a humanitarian device exemption as an adjunct with sutures or staples in aortic dissection procedures. The HDE allows use of the adhesive to "facilitate surgical repair of acute thoracic aortic dissections by obliterating the false channels and strengthening the friable diseased aortic tissue for suture placement"
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