Prescient Surgical releases first device of many for reducing surgery site infection

Orange County, CA - January 31st 2017 -  California Company Prescient Surgical has recently won FDA de novo clearance for their wound retraction and protection system, CleanCision. The circular device is able to expand and rescind in order to hold incisions open and prevent hands or instruments from touching the wound.  Made for abdominal surgery, the device continuously irrigates the wound edge for protection against contamination and potential infection at surgical site.

The FDA’s de novo clarification is for innovative, low-risk devices to be reviewed and improved rather than falling into the heavily regulated 510(k) submission and PMA applications which require pre-market approval to determine which of their three classification categories the device belongs to. Granted by the FDA’s Center for Devices & Radiological health, it’s the first device in a new category of irrigating wound protection technology. Prescient Surgical has a broad portfolio of devices in development in the prevention of surgical infections. Their first device, the CleanCision, is dedicated to helping those most at risk for developing infection; patients undergoing high-risk abdominal gastrointestinal surgery. Up to 48% of wounds are contaminated during this type of procedure and 13-36% result in infection.

The CleanCision has radial expanding that is compatible with incisions ranging from 7-16 cm in length and contains a two-layered barrier. This allows the device to be deployed quickly and with ease compared to similar devices. While deployed, the device is able to use a hands-free irrigation system to allow a sterile solution to be delivered along the wound’s edge.

Prescient Surgical releases first device of many for reducing surgery site infection

The irrigant solution is delivered through a gravitational feed via luer connection to a standard IV bag. The solution flows into the device and through the permeable barrier to deliver the solution to the wound site and removes excess solution through a separate chamber in the barrier connected to and outside suction canister. Its flexibility reduces the need for multiple devices, lowers expenses, and reduces the required amount of storage space.

The only intraoperative device currently available, its unique form combines Intraoperative wound irrigation (IOWI) and continuous wound edge protection (CWEP), two practices proven to reduce surgical site infection and the risk of contamination. In fact, pre-clinical studies have shown that CleanCision achieves sustained reductions in postoperative bacterial contamination.

The device will be available for commercial use in early 2018. For more information visit their site here.

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Ampronix is a renowned authorized master distributor of the medical industry's top brands as well as a world-class manufacturer of innovative technology. Since 1982, Ampronix has been dedicated to meeting the growing needs of the medical community with its extensive product knowledge, outstanding service, and state-of-the-art repair facility. Ampronix prides itself on its ability to offer tailored, one-stop solutions at a faster and more cost-effective rate than other manufacturers. Ampronix is an ISO & ANSI/ESD certified facility. To learn more go here.

Prescient Surgical releases first device of many for reducing surgery site infection Orange County, CA – January 31st 2017 –  California Company Prescient Surgical has recently won FDA de novo clearance for their wound retraction and protection system, CleanCision. The circular device is able to expand and rescind in order to hold incisions open and prevent […]