2000
DOI: 10.1089/pei.2000.4.7
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A Clinical Evaluation of the Use of Radially Expandable Laparoscopic Access Devices in the Pediatric Population

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Cited by 6 publications
(2 citation statements)
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References 13 publications
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“…This system has been studied extensively and information about its use has been presented at several major medical conferences and published in several reference journals. [3][4][5][6][7][8][9][10][11][12][13][14] Recently, this scientific information was submitted to the US Food and Drug Administration (FDA), which cleared the device for additional safety advertising claims. The FDA acknowledged that the Step radially expanding laparoscopic access technology provides safety benefits including, but not limited to: (i) a lower incidence of abdominal wall bleeding; (ii) a lower prevalence of bowel and bladder injuries; (iii) a lower incidence of postoperative incisional hernias, and (iv) a lower prevalence of major vascular injury.…”
Section: Thementioning
confidence: 99%
“…This system has been studied extensively and information about its use has been presented at several major medical conferences and published in several reference journals. [3][4][5][6][7][8][9][10][11][12][13][14] Recently, this scientific information was submitted to the US Food and Drug Administration (FDA), which cleared the device for additional safety advertising claims. The FDA acknowledged that the Step radially expanding laparoscopic access technology provides safety benefits including, but not limited to: (i) a lower incidence of abdominal wall bleeding; (ii) a lower prevalence of bowel and bladder injuries; (iii) a lower incidence of postoperative incisional hernias, and (iv) a lower prevalence of major vascular injury.…”
Section: Thementioning
confidence: 99%
“…This has raised concerns regarding the safety of pediatric laparoscopy. Studies have reported various complication rates [1][2][3][4]. Most complications are related to the insertion of the first port [5], and there are various methods for doing this.…”
Section: Introductionmentioning
confidence: 99%