In Brief: Closure Medical's DermaBond
This article was originally published in The Gray Sheet
Executive Summary
Closure Medical's DermaBond: FDA's General and Plastic Surgery Devices panel unanimously recommends approval with conditions (8-0) of a premarket approval application for the sterile, liquid tissue adhesive for the proposed indication of topical use to "hold closed, approximated wound edges of trauma-induced lacerations or surgical incisions, including punctures from minimally invasive surgery, which otherwise could be closed with sutures of USP size 5-0 or smaller in diameter, staples, or adhesive strips." Panel members highlighted data showing that three-month cosmesis results with DermaBond were equivalent to control devices. The panel conditions its Jan. 30 recommendation on a brief addition to labeling that reminds physicians that adequate wound cleansing must be performed prior to DermaBond treatment. Panel members also recommend that labeling should state that the device is not intended to replace clinically indicated sub-dermal suture closure. Results of the company's prospective, controlled, randomized study, which involved more than 814 evaluable patients at 10 sites, showed the device to be safe and effective, the panel concluded...