Organogenesis Gets 510(k) Clearance to Expand PuraPly Portfolio
Canton, Mass.-based Organogenesis has received 510(k) marketing clearance from the FDA for PuraPly MZ, a new addition to its PuraPly regenerative wound management product line.
MZ stands for micronized (powdered) and the product is a porcine collagen designed to support healing in deep and complex wounds. The powder, which is supplied in a single-use vial, maintains optimal contact with the contours of the wound.
Collagen plays an important role in wound healing by supporting the formation of new blood vessels and tissue, and the removal of damaged or infected tissue.
The product should not be used in patients with known sensitivity to porcine material and should not be applied until excessive exudate, bleeding, acute infection and significant swelling are controlled, according to the product labeling.
Organogenesis is focused on developing tools for advanced wound care for surgical and sports medicine use.