Helios Cardio Inc. announces the Food and Drug Administration (FDA) 510(k) clearance for commercial distribution of CardiaMend™ Pericardial and Epicardial Reconstruction Matrix.
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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.”
About Engineered Biologic Matrix
Engineered Biologic Matrix (EBM) has been employed in many surgical indications since 2003. As an implantable medical device in critical applications such as dura mater repair, hernia repair, and plastic and reconstructive surgery, EBM has a rich heritage of exceptional clinical safety and performance.
An exceptionally pure collagen scaffold, EBM is free of non-collagen proteins, lipids, growth factors, or other inflammatory cellular remnants. It is the only biologic matrix containing abundant levels of collagen Type III, which is involved in “scarless healing” observed in fetal and neonatal mammals. When implanted, EBM provides signals to a variety of cell surface receptors stimulating tissue regeneration and attenuating fibrosis.
About Helios Cardio Inc.
Led by a team with a successful heritage in regenerative medicine spanning over 20 years, Helios Cardio intends to improve clinical outcomes for patients suffering from some of the most challenging cardiovascular conditions for which there remains a significant unmet medical need. These include chronic heart failure, complications associated with open heart surgery, and other heart repair indications, for which only sub-optimal solutions exist .