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| http://www.prescientsurgical.com/ |
Prescient Surgical got green signal from FDA’s Center for Devices & Radiological health for
de novo clearance of its CleanCision wound retraction and protection system. The clearance could not have come at better
time because "Hospitals are increasingly focusing on infection control to
improve patient care as a primary goal. Prescient's success with the
CleanCision device bodes well for providers driven towards the 'triple aim' of
quality of care, patient satisfaction, and reduced costs,"says Brant Heise,
Managing Director at Summation Health Ventures.
This system
is used by surgeons during abdominal surgery to retract the surgical incision,
providing easy access to the surgical site while protecting the edges with an
impermeable barrier thereby reducing the chances of wound infection.
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| http://www.prescientsurgical.com/ |
The CleanCision is a novel device, first of
its kind and aids in the prevention of wound edge contamination. The device has
a radial fan like expanding system that is suitable for incisions ranging from
7-16 cm.
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| http://www.prescientsurgical.com |
Irrigant
fluid is delivered to the wound edges by gravitational force from an external
fluid bag and excess is drained via a suction connected to the device. The impermeable
inner layer of retractor prevents the wound contamination by fluids in the
operative field.
Wound irrigation
and barrier wound protections are two strategies that have proved to reduce surgical
site infection (SSI) are combined effortlessly in this one of its kind device.
Prescient
Surgical CEO Jonathan Coe said in a statement "This news from the FDA marks a crucial milestone for
Prescient Surgical and validates the hard work put in by our team and clinical
partners towards our mission of reducing the risk of SSI. Most importantly, we
can now look toward extending the promising results we've seen in recent
clinical trials to the broader patient population."
Surgical
site infections are the most common reason behind nosocomial infection, accounting
for 31% of all Hospital Acquired Infections (HAIs) among hospitalized patients.[1]
The full product brochure can be accessed here.
[1] Magill,
S.S., et al., "Prevalence of healthcare-associated infections in acute
care hospitals in Jacksonville, Florida". Infection Control Hospital
Epidemiology, 33(3): (2012): 283-91.
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