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# Helios Cardio’s CardiaMend Cleared by FDA
- URL: https://www.fdaweb.com/helios-cardios-cardiamend-cleared-by-fda/
- Published: 2022-01-05T12:00:00.000Z
- Updated: 2026-09-14T17:27:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150874

FDA has cleared a Helios Cardio 510(k) for CardiaMend Pericardial and Epicardial Reconstruction Matrix, an acellular collagen matrix derived from fetal bovine dermis that is indicated for both pericardial repair and reconstruction, and epicardial support and repair. The device is supplied in a variety of sizes and two thickness specifications.

The company says the matrix is free of non-collagen proteins, lipids, growth factors, or other inflammatory cellular remnants. It contains collagen Type III, which promotes “scarless healing” and “signals to a variety of cell surface receptors stimulating tissue regeneration and attenuating fibrosis,” the company says.