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FDA approves Prescient CleanCision wound retraction and protection system

MDBR Staff Writer Published 20 December 2017

The US Food and Drug Administration (FDA) has given 510(k) clearance to Prescient Surgical's new CleanCision wound retraction and protection system.

CleanCision has been developed by surgeons and infection control experts to provide protection from pervasive sources of surgical infection.

The advanced wound protection system will destroy harmful bacteria that may invade the incision during surgery.

Through using active cleansing technology, CleanCision is said to combine wound protection and irrigation into a retraction system to protect the wound site.

CleanCision will access the surgical site and applies sterile irrigant solution selected by the surgeon to clear contamination invading the surgical incision.

The wound edge is continuously and consistently irrigated, while suction clears contaminants during the surgery.

CleanCision has secured approval for use in abdominal surgery and prevent wound edge contamination.

The company will offer CleanCision system through its Early Access Program, which was designed to help surgical teams assess the impact of the device.

Prescient Surgical president and CEO Jonathan Coe said: "We are initially focusing on abdominal surgery and particularly colorectal surgery, where the risk, frequency and severity of surgical site infection is high and the need is acute.

"Our team collaborated closely with leading hospitals in abdominal surgery to create a technology platform and product that could be used in the full range of open and minimally invasive approaches utilized in their procedures.”

Based in San Carlos of California, Prescient Surgical is engaged in the development of advanced tools and technologies to prevent surgical site infection.


Image: CleanCision system will clear harmful bacteria during the surgery. Photo: courtesy of PRNewsFoto / Prescient Surgical.