Helios Cardio announces US FDA 510(k) clearance for a new Pericardial and Epicardial Reconstruction Matrix

Offers cardiac surgeons with a best-in-class biomaterial indicated for pericardial repair and reconstruction, and epicardial support and repair

Helios Cardio Inc. announces the Food and Drug Administration (FDA) 510(k) clearance for commercial distribution of CardiaMend™ Pericardial and Epicardial Reconstruction Matrix.

CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is a unique acellular collagen matrix derived from fetal bovine dermis (EBM), combining class leading strength without chemical crosslinking, together with abundant levels of collagen type III mediating healing and inhibiting scarring.

Indicated for both pericardial repair and reconstruction, and epicardial support and repair, CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is supplied in a variety of sizes and two thickness specifications providing surgeons with the widest flexibility for each procedure, technique, and patient.

"We are looking forward to providing cardiac surgeons with the strongest and most regenerative biologic implant available to date." said Yiannis Monovoukas, PhD, CEO of Helios Cardio. "Our intention, however, is not to stop there, but to further extend the functionality of CardiaMend™ towards true cardiac tissue regeneration, and to achieve our ultimate goal of mending broken hearts."