FDA Nod For S&N’s PICO Portable Negative Pressure Wound System


Smith & Nephew plc has followed last year’s launch of PICO in Europe, Canada, and Australia by announcing that its pocket-sized PICO single use Negative Pressure Wound Therapy (NPWT) system has now received FDA clearance. PICO is indicated for use both in a hospital and homecare setting and expands the use of NPWT from the traditional wound care population to include a wider range of patients undergoing orthopaedic surgery, plastic surgery and general surgical procedures.

The PICO System

The PICO system is indicated for chronic, acute and traumatic wounds, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts, and closed surgical incisions. The PICO system is as easy to apply as a conventional wound dressing, reducing the need for the staff time, intensive training and administrative paperwork associated with traditional NPWT.

The system is fully disposable, comes complete with two AA batteries and works for 7 days. the pack includes two dressings in the event that a dressing change is deemed necessary within the lifespan of the device.

For the patient there are undoubted benefits with the PICO system. The one-button pump is easy-to-use and its small size and silent operation provide a discreet, unobtrusive way to carry on daily life with NPWT. The disposable device works with a revolutionary dressing technology that manages fluids, eliminating the need for bulky canisters. The system can be worn on a wound up to a week, depending on the level of exudates and its gentle silicone wound contact layer helps minimize pain at a dressing change.

Smith & Nephew  claims the PICO system is more affordable than traditional NPWT, and can significantly reduce therapy costs associated with traditional NPWT, although this presumably only means in direct comparison as the company also suggests that its availability increases the number of patients for whom NPWT is an option. If PICO does expand the market by making NPWT available for a wider population than is currently the case then the economic argument for its use will need to be based on NPWT (Using Pico) vs alternative/no treatment rather than PICO vs traditional NPWT.

To support its economic arguments further, the company claims that by being available off the shelf, the PICO system may reduce the occurrence of delayed hospital discharges.

Clinician comments

“PICO is novel and beneficial in several regards,” said Dr. Raymond Dunn, Chairman of Plastic Surgery, University of Massachusetts. “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. With the simple pump, on-off design and absence of any canister or reservoir for fluid, patients can manage their NPWT at home much more easily, without additional nursing visits. This saves the healthcare system money and improves patients’ quality of life.”

Company comments

“We are the first company to deliver effective, single use disposable NPWT using the combination of a small, portable pump and advanced dressing technology,” said Thomas Dugan, President, Advanced Wound Management, North America. “The PICO system demonstrates our commitment to innovation and reinforces our pledge to help reduce the human and economic cost of wounds.”

Source: Smith & Nephew plc