Use of claims data for device problem tracking wins support in US regulatory and industry circles
This article was originally published in Clinica
Executive Summary
US Medicare claims data could be helpful as a post-marketing surveillance tool for high-risk devices, researchers at Dartmouth Medical School have concluded after using the data to determine possible risks associated with drug-eluting stents. The researchers were trying to determine whether Johnson & Johnson's Cypher stent posed a higher risk of sub-acute thrombosis, as the FDA had feared in the early months after release of the product.