Thursday, 18 October 2018

Prescient Surgical got FDA 510(k) clearance for Its novel CleanCision system

20 December 2017 | News

Surgeons and infection control experts develop new class of advanced technology to fight and defend against surgical site infection

Prescient Surgical, Inc. located in San Carlos, Calif. is a medical device innovator that makes advanced tools and technologies to fight and defend against the sources of surgical site infection.

The company announced that the U.S. Food and Drug Administration (FDA) have cleared the CleanCision Wound Retraction and Protection System (CleanCision System) for commercialization in the United States. 

Developed by surgeons and infection control experts, CleanCision is the first in a new class of advanced technology.

It is designed to fight and defend against the most pervasive sources of surgical infection.

Utilizing active cleansing technology, CleanCision combines wound protection and irrigation in simple and effective retraction system that actively, consistently, and continuously clears harmful bacteria that may invade the incision during surgery. 

When the threat of wound contamination is at its highest, CleanCision has been shown to reverse and reduce these pervasive sources of infection, clearing harmful bacteria throughout surgery.

CleanCision can put more control over the root causes of infection into the hands of surgical teams where traditional methods fail to do so.

Easily deployed to retract and protect the wound site, CleanCision provides access to the surgical site and uses a sterile irrigant solution, selected by the surgeon, to clear contamination invading the surgical incision.

The wound edge is continuously and consistently irrigated while suction removes contaminants throughout the surgery.

CleanCision is cleared for use in abdominal surgery and may aid in the prevention of wound edge contamination. 

Hospitals can acquire CleanCision through the company's Early Access Program, developed to help surgical teams implement and measure the impact of the device as part of their infection reduction programs.

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