The new approval grants BD the ability to move forward with a new device aimed at repairing abdominal hernias.
The US Food and Drug Administration (FDA) is giving 510k clearance to the Phasix ST Mesh with Echo 2 Positioning System for ventral hernia repair as an alternative to permanent mesh.
The new system represents the only bioresorbable mesh with a removable positioning system aimed as simplifying minimally invasive hernia repairs, combining 2 of BD’s technologies into a single product.
The Phasix ST Mesh is a long-lasting naturally derived bioresorbable mesh with a hydrogel barrier for intraabdominal placement to create a strong repair without needing a permanent implant.
The Echo 2 Positioning System is a pre-attached deployment and position device that facilitates accurate and consistent mesh placement in minimally invasive hernia repairs.
“Hernias are prevalent in the US and worldwide, either as a result of naturally occurring weaknesses of the human abdominal wall or as a result of previous surgeries,” Namir Katkhouda, MD, professor of Surgery, University of Southern California, said in a statement. “While effective care options exist for patients, Phasix ST Mesh with Echo 2 Positioning System works with the body to rebuild tissue while gradually and predictably remodeling the area of weakness to provide a more durable repair.”
In preclinical testing, investigators found the positioning system could save up to 30% more time during mesh placement compared to traditional flat mesh. The new mesh system demonstrated that it could help enable rapid tissue ingrowth while providing twice the strength of other bioresorbable mesh.
“With more than 50 years of experience in hernia repair, we are continuing to innovate and improve upon treatment options to ensure clinicians have access to the latest technology to treat their patients,” Michael Garrison, worldwide president of Surgery at BD, said in a statement. “Phasix ST Mesh's promising results in the treatment of hernias, coupled with the deployment technology of the Echo 2™ Positioning System, has the potential to make this device the preferred choice for surgeons performing abdominal hernia surgeries.”