Corgenix submits 510(k) filing for cardiovascular diagnostic technology AtherOx

By Elaine Rigoli

Tampa, Fla., March 29 - Corgenix Medical Corp. has submitted a 510(k) premarket notification submission to the Food and Drug Administration for AtherOx, a patented technology to identify individuals at risk for developing atherosclerotic cardiovascular disease.

"Based on promising preclinical data, and wide acceptance of this next-generation predictive cardiovascular diagnostic line in Europe and Asia, we are extremely enthusiastic about the potential of AtherOx as a new marker in the evaluation of cardiovascular disease in the United States," chief executive officer Douglass Simpson said in a news release.

AtherOx uses a combination of oxidized low-density lipoprotein and B2GPI, a plasma protein that participates in thrombosis.

Although oxLDL has been implicated in cardiovascular disease, clinical data demonstrates that the determination of AtherOx, rather than of oxLDL alone, is a more accurate assessment of the risk of progressive atherosclerotic cardiovascular disease, the release said.

Corgenix, located in Denver, develops specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders.

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