Smith+Nephew announces US launch of PICO(TM) 14 Single Use Negative Pressure Wound Therapy System for use on high risk surgical patients

LONDON, March 3, 2020 /PRNewswire/ -- Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business, today announces the US launch of the new PICO 14 Single Use Negative Pressure Wound Therapy System (sNPWT) which has a pump duration of up to 14 days.¹ The new pump builds on the features and advantages of previous PICO sNPWT variants, and comes with an enhanced pump which requires less user intervention.^2*

14 days of therapy may be particularly relevant for patients where both the risk of surgical site complications (SSCs) and the consequence of obtaining them are high, such as cardiothoracic surgery and abdominal surgery. Complications following coronary artery bypass graft surgery (CABG) can devastate patient lives, with up to a 35% in hospital mortality rate associated with deep sternal wound infections and mediastinitis and length of stay as long as 23 days per patient,⁴ which incurs substantial healthcare associated costs.⁵ Following colorectal surgery the consequences to the patient and healthcare system of a surgical site infection (SSI) have a similar impact with hospital lengths of stay as high as 28 days in a surgery speciality that also has one of the highest incidences of SSI rates of up to 28%.⁶ 

In one study prophylactic use of PICO sNPWT significantly reduced the incidence of wound complications by 70% following coronary artery bypass graph surgery compared with standard dressings.^7*** In a study of elective and emergency abdominal surgery PICO sNPWT demonstrated  a 74%  reduction in surgical site infection rate at 30 days postoperatively compared to standard dressings.^8†

"With PICO 14 we continue to demonstrate our commitment to healthcare professionals and patients' evolving needs." said Paolo Di Vincenzo, Senior Vice President US Commercial, Smith+Nephew. "This innovative sNPWT system delivers additional design improvements that contribute to patient management and health care professional efficiency,⁹ keeping Smith+Nephew at the forefront of delivering innovative negative pressure solutions."

The risk of developing a post-operative wound complication depends on the type of surgery and patient risk factors. The presence of just one major risk factor, like BMI higher than 40 and uncontrolled diabetes mellitus, or two or more moderate risk factors, like advanced age and smoking, places patients at high risk of surgical site complication.¹⁰

The PICO^™ sNPWT dressing includes a proprietary AIRLOCK™ Technology layer that uniformly and consistently delivers sufficient NPWT across a surgical incision and the surrounding zone of injury.^9,11 This unique feature is designed to help reduce the risk of wound complications by reducing post-operative fluid ^{(KAR, PAY)12,13} and tension^**14 around a closed surgical incision, when compared with standard dressings. The combination of these actions helps reduce the risk of surgical wound dehiscence¹⁵ and SSIs¹⁵, the two most common surgical site complications.

To read more about PICO sNPWT, please visit www.possiblewithpico.com.

For detailed product information, including indications for use, contraindications, precautions and warnings, please consult the product's applicable Instructions for Use (IFU) prior to use.

* compared to previous versions
** as demonstrated in biomechanical modelling
***n=80; p<0.034
† n = 50; p=0.043; There was no difference in SSIs at 4 days postoperatively

References
1.   Smith & Nephew December 2018. PICO 14 Service Life Testing: 14 Day Device Lifespan. Internal Report. RD/18/132.
2.   Smith & Nephew. Research & Development Report. PICO 14 and PICO 7 Initial Pump Down and Maintenance Pump Down Time Outs RD/19/084
3.   El Oakley, R.M. and Wright, J.E., 1996. Postoperative mediastinitis: classification and management. The Annals of thoracic surgery, 61(3), pp.1030-1036.
4.   Jenks, P.J., Laurent, M., McQuarry, S. and Watkins, R., 2014. Clinical and economic burden of surgical site infection (SSI) and predicted financial consequences of elimination of SSI from an English hospital. Journal of Hospital Infection, 86(1), pp.24-33.
5.   Zimlichman E, Henderson D, Tamir O, et al. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA internal medicine. 2013;173(22):2039-2046.
6.   Tanner et al. (2009), Post-dischargesurveillance to identify colorectal surgical site infection rates and related costs, J Hosp Infect 72; 243-250.
7.   Witt-Majchrzak, A., Żelazny, P. and Snarska, J., 2015. Preliminary outcome of treatment of postoperative primarily closed sternotomy wounds treated using negative pressure wound therapy. Polish Journal of Surgery, 86(10), pp.456-465.
8.   O'Leary D.P. et al. Prophylactic negative dressing use in closed laparotomy wounds following abdominal operations. A randomised, controlled, open-label trial: The PICO trial. Ann Surg. 2017; Jun 265(6):1082-1086.
9.   Smith & Nephew October 2017. Project Opal PICO 7 System Stability Testing, Initial Time Point. Internal Report. DS/17/253/R.
10. Sugrue M, Ciprandi G, Djohan R, et al. World Union of Wound Healing Societies (WUWHS) Consensus Document. Closed surgical incision management: Understanding the role of NPWT. Wounds Int [Internet]. 2016.www.woundsinternational.com/wuwhs/view/consensus-documentclosed-surgical-incision-management-understanding-the-roleof-npwt (Accessed December 2019)
11. Malmsjö M, Huddleston, E., and Martin, R., .Biological Effects of a Disposable, Canisterless Negative Pressure Wound Therapy System. ePlasty. 2014;14.
12. Karlakki SL, Hamad AK, Whittall C, et al.Incisional negative pressure wound therapy dressings (iNPWTd) in routine primary hip and knee arthroplasties: A randomised controlled trial. Bone Joint Res. 2016;5(8):328-337.
13. Payne C, Edwards D.Application of the Single Use Negative Pressure Wound Therapy Device ( PICO ) on a Heterogeneous Group of Surgical and Traumatic Wounds. ePlasty. 2014:152-166.
14. Loveluck J, Copeland, T., Hill, J., Hunt, A., and Martin, R., .Biomechanical Modeling of the Forces Applied to Closed Incisions During Single-Use Negative Pressure Wound Therapy. ePlasty. 2016.
15. Smith & Nephew. April 2019. Outcomes following PICO compared to conventional dressings when used prophylactically on closed surgical incisions: systematic literature review and meta-analysis. Report reference EO/AWM/PICO/004/v3.

About Smith+Nephew

Smith+Nephew is a portfolio medical technology business that exists to restore people's bodies and their self-belief by using technology to take the limits off living. We call this purpose 'Life Unlimited'. Our 17,500+ employees deliver this mission every day, making a difference to patients' lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global franchises of Orthopaedics, Advanced Wound Management and Sports Medicine & ENT.

Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.1 billion in 2019. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms 'Group' and 'Smith+Nephew' are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on Twitter, LinkedIn, Instagram or Facebook.

To learn more about how we can help you get CLOSER TO ZERO™ surgical site complications, please visit www.closertozero.com

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew's most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew's expectations.

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