Shelhigh
This article was originally published in The Gray Sheet
Executive Summary
Humanitarian device exemption for Shelhigh's pulmonic valve conduit Model NR-4000 with "No-React" treatment is approved by FDA Nov. 8. The device is indicated for "replacement of the diseased, damaged, or absent pulmonic artery in small children or infants up to age 4 years, with transposition of the great arteries, truncus arteriosis, tetrology of fallot with associated cardiac anomalies or with pulmonary atresia, or replacement of failed conduits in young patients with accelerated conduit failure." The agency is requiring the firm to track the device because it is a permanent implant, the failure of which would be likely to have serious adverse consequences