FDA clears TyRx' PIVIT AB antimicrobial-coated surgical mesh:
This article was originally published in Clinica
TyRx Pharma has received US FDA 510(k) clearance to sell an antimicrobial-coated version of its PIVIT surgical mesh. PIVIT AB not only improves patient comfort, as with the earlier device, it also reduces bacterial colonisation of the product during its implantation. It is coated with a bioresorbable polymer containing rifampin and minocycline; the antimicrobial-free version of the device was cleared for sale last year. The Monmouth Junction, New Jersey firm says that its products leave less implant material in the body following the resorption of the bioresorbable polymer coating, a property that is expected to help facilitate patient comfort during the post-operative period and beyond. PIVIT AB is indicated for repairing hernias and other abdominal fascial deficiencies.