Prescient Surgical, a company out of San Carlos, California, won FDA’s de novo regulatory clearance to introduce its CleanCision Wound Retraction and Protection System. Receiving de novo clearance means this is the first device of its kind, and it is novel.
The expanding wheel-like device opens and holds the wound retracted for easy access. It prevents hands or instruments from touching the incision, and actually provides an irrigation system to deliver a sterile solution from a nearby fluid bag to the tissue, thus further helping to prevent infections.
The CleanCision has a porous layer that touches the skin, so the irrigation fluid can be delivered in and out, and a protective outer layer that doesn’t let liquids through.
More from Prescient Surgical:
Intraoperative wound irrigation (IOWI) and continuous wound edge protection (CWEP) are independently proven practices for reducing surgical site infection and the risk of wound contamination. CleanCision is the first in a new class of irrigating wound protection devices to provide self-retaining wound retraction, continuous wound edge protection, and intraoperative wound edge irrigation with a sterile irrigant solution. CleanCision is the only intraoperative device capable of combining the synergistic benefits of continuous intraoperative wound edge irrigation and protection, integrated into a universal abdominal access platform
Product page: CleanCision…