ATS' Dermagraft
This article was originally published in The Gray Sheet
Executive Summary
Treatment investigational device exemption for the bioengineered human skin graft in the treatment of diabetic foot ulcers is approved by FDA, according to Advanced Tissue Sciences, which says it will focus on a "small number of centers" while working with the Health Care Financing Administration and other payers to address reimbursement. The treatment IDE study will be conducted concurrently with the firm's ongoing clinical trial ("The Gray Sheet" Aug. 10, In Brief). FDA requested the additional study in June to support the firm's premarket approval application for Dermagraft ("The Gray Sheet" June 15, p. 5)