Helios Cardio Gets FDA’s 510(K) Clearance for Its Reconstruction Matrix

January 7, 2022

Helios Cardio has received the FDA’s 510(k) clearance for its CardiaMend pericardial and epicardial reconstruction matrix.

A collagen matrix derived from fetal bovine dermis, CardiaMend provides healing while inhibiting scarring, according to the company.

The matrix, which is indicated for pericardial repair and reconstruction, and epicardial support and repair, is available in a variety of sizes and thickness specifications.

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