Smith & Nephew wound therapy system gets FDA clearance

9 January 2012 (Last Updated January 9th, 2012 18:30)

The US Food and Drug Administration (FDA) has cleared Smith & Nephew's pocket-sized PICO system, a single-use negative pressure wound therapy system for use both in a hospital and homecare setting.

The US Food and Drug Administration (FDA) has cleared Smith & Nephew's pocket-sized PICO system, a single-use negative pressure wound therapy system for use both in a hospital and homecare setting.

The PICO system is designed for chronic, acute and traumatic wounds, subacute and dehisced wounds, partial-thickness burns, ulcers (including diabetic and pressure), flaps and grafts, and closed surgical incisions.

The wound dressing system reduces the amount of staff time, intensive training and administrative paperwork associated with traditional negative pressure wound therapy.

It uses a revolutionary dressing technology that manages fluids, eliminating the need for bulky canisters, and can be worn on a wound up to a week, depending on the level of exudates.

The initiative follows the recent successful launch of PICO in Europe, Canada, and Australia.

University of Massachusetts Plastic Surgery chairman Raymond Dunn said that with the simple pump, on-off design and absence of any canister or reservoir for fluid, patients can manage negative pressure wound therapy at home, without additional nursing visits, which saves the healthcare system money and improves patients' quality of life.

"The seven day duration should allow us to more rapidly transition care for patients with post-operative wounds and skin grafts to the outpatient setting,'' Dunn said.

The company intends to expand the use of the system from the traditional wound care population to include a wider range of patients undergoing orthopaedic surgery, plastic surgery and general surgical procedures.