Vascutek's Gelseal
This article was originally published in The Gray Sheet
Executive Summary
Inchinnan, Scotland-based manufacturer of vascular prostheses plans to begin sales of its Dacron-knitted, bovine gelatin- impregnated Gelseal vascular grafts in the U.S. this month through its distributor Impra. Designed to minimize blood loss, the presealed grafts received FDA approval on Jan. 11 for abdominal applications. Austin, Texas-based Carbomedics, which provided regulatory assistance to Vascutek, is listed as the applicant in FDA's January report of PMA approvals ("The Gray Sheet" March 1, p. 10); both Carbomedics and Vascutek are subsidiaries of Winterthur, Switzerland-based Sulzermedica. Gelseal received a unanimous approval recommendation from FDA's circulatory system devices panel in June 1991 ("The Gray Sheet" June 10, 1991, p. 13). The grafts currently are marketed in Europe, Japan, Canada, Australia, South Africa and Korea.