Kerecis has secured approval from the US Food and Drug Administration (FDA) for its Omega3 SecureMesh for use in surgical applications.
The Omega3 SecureMesh has been approved for use in lung, bariatric, gastric, colorectal and other surgeries.
Kerecis Omega3 is intact fish skin rich in naturally occurring Omega3 polyunsaturated fatty acids.
The material, which can be used to regenerate damaged human tissue, holds capacity to stimulate healing.
According to the company, the new device has been developed on collaboration with the US Office of Naval Research.
Generally, the surgical staplers are used during laparoscopic operations to simultaneously cut organs and staple the resulting organ wound closed.
Kerecis Omega3 fish-skin product will be used to strengthen the staple line and reduce the possibility of leakage.
Kerecis Omega3 material enrolls the body’s cells from the tissue surrounding the organ cut. These will be integrated into the fish skin and converted into functional living tissue.
Earlier, the company’s Omega3 Wound product was approved by FDA for wound healing.
Kerecis president and chairman Fertram Sigurjonsson said: ”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.”