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FDA Clears Smith & Nephew’s Single-Use Negative Pressure Wound Therapy System

January 6th, 2012 Shiv Gaglani Plastic Surgery, Surgery, Vascular Surgery


The human body’s first layer of defense – skin – can be compromised in many ways: abrasions, burns, and cuts, to name a few. Deep wounds require deep cleansing in order to prevent the development and spread of infections. Over the last two decades the wound treatment community has seen an increasing use of negative pressure (that is, vacuum) pumps in order to tightly seal wound dressings and remove edema, or fluid buildup.

The London-based medical device company Smith & Nephew announced today that the FDA cleared its newest device, PICO, which is a single-use negative pressure wound therapy (NPWT) system. According to the press release, PICO offers several advantages to heatlhcare providers, patients, and payers alike:

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.

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.

For more information about the system, please follow the links below and watch this video about NPWT:

Press release: FDA clears PICO Single Use Negative Pressure Wound Therapy System from Smith & Nephew, expanding patient access

Official website: Possible with Pico

 

Shiv Gaglani

Shiv Gaglani is an MD/MBA candidate at the Johns Hopkins School of Medicine and Harvard Business School. In addition to curating the Smartphone Physical (www.smartphonephysical.org), he also contributes regularly to CardioSource World News and Emergency Physicians Monthly. He is interested in developing scalable, tech-based solutions for medicine and education; to this end he is the co-founder of the medical education tech start-up, Osmosis (www.osmosis.org).  More about Shiv: http://about.me/sgaglani

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