FDA Clears PICO* Single Use Negative Pressure Wound Therapy System–Instructions for Application Use Provided by a MS Tag (barcode) On Packaging

The device is available off the shelf and can be used at home or in hospital and is disposable and works for about a week. The device manages fluids and is small enough so it can be carried discreetly for patients being treated. The PICO unit has already been approved in other countries and it can be used after plastic surgery or other general surgical procedures. Smith and Nephew is also the same company that said last year that they have a 30 year knee replacement.

I’m impressed to see MS Tags (bar codes) used here and if you read here often enough you can see the links at the top of this page where I think they would be real benefit for FDA Recalls, drugs and devices. BD

Press Release:

ST. PETERSBURG, Fla., Jan. 6, 2012 -- Smith & Nephew plc , the global medical technology business, announces the FDA clearance of the pocket-sized PICO* system, a single use Negative Pressure Wound Therapy (NPWT) system. PICO is cleared 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 orthopedic surgery, plastic surgery and general surgical procedures. This FDA clearance follows the recent successful launch of PICO in Europe, Canada, and Australia.

"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."

Smith & Nephew has been a leader in the wound care market for more than a century. The company has employed years of customer feedback and market research in the PICO system's design to ensure a patient friendly experience that addresses the needs and preferences of clinicians and payers as well.

Clinicians can be confident that the PICO system is providing NPWT safely and effectively in a wide range of wounds and care settings. 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 simple application technique can be viewed online via an MS Tag included on the packaging.

For the patient, the PICO system's 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. Its gentle silicone wound contact layer helps minimize pain at a dressing change.

For the Payer, the PICO system is more affordable than traditional NPWT, and can significantly reduce therapy costs associated with traditional NPWT. The PICO system is available off-the-shelf and therefore may reduce the occurrence of delayed hospital discharges.

"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, Smith & Nephew 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."

Clinicians and patients can also refer to the 24/7 negative pressure wound therapy hotline, 866-998-NPWT (6798), for more information about the NPWT portfolio of products from Smith & Nephew.

For more information about the PICO system, please visit our mobile compatible website at www.possiblewithpico.com or follow the @woundcare Twitter handle for the latest news from the Advanced Wound Management division of Smith & Nephew. Register at www.twitter.com today.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/51011-smith-nephew-pico-system-fda-approval-npwt