Kerecis said today that it won 510(k) clearance from the FDA for its Kerecis Omega3 SecureMesh regenerative surgical mesh for use in lung, bariatric, gastric, colorectal and other surgeries.
The McLean, Va.-based company said the Kerecis Omega3 mesh is made from intact fish skin saturated in naturally occurring Omega3 polyunsaturated fatty acids. Kerecis said the material is designed to regenerate human tissue and “has the potential to accelerate healing.”
“With diabetes and obesity so common today, improved surgical technologies are needed to cope with more stress and tissue mass. Our technology can help improve outcomes by reducing the possibility of leakage from surgical wounds. The FDA approval represents an important milestone for us, as we now have two approved products in the world’s largest market for surgical products,” CEO Fertram Sigurjonsson said in prepared remarks.
Kerecis said the Omega3 mesh can be used to strengthen staple lines to reduce leakage during laparoscopic operations. The mesh is designed to “recruit the body’s cells from the tissue surrounding the organ cut” and integrate the cells into the fish skin mesh, which will eventually convert into living tissue.