Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT000314

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel