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Smith & Nephew launches PICO™ 7Y, the first portable single use negative pressure wound therapy system to treat two wounds simultaneously

16 October 2018

PICO 7Y product image

Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, is pleased to announce the European launch of the new PICO 7Y Single Use Negative Pressure Wound Therapy System (sNPWT) with AIRLOCK™ Technology. This is the first sNPWT system to include an innovative integrated Y extension enabling the utilisation of two dressings concurrently from one pump, in practice allowing for two wounds to be addressed at the same time, thereby potentially reducing cost.

PICO 7Y sNPWT includes extended soft port and multisite dressings, designed to conform to complex anatomies.[1] It is particularly suited for use on multiple wounds, such as breast surgical procedures. PICO 7Y also includes a check dressing indicator, which is intended to reduce unnecessary dressing changes and wastage[2],[3] and is 23% quieter than the first generation PICO,[4],[5] making it less intrusive for patients.

“With breast surgical procedures becoming more frequent,[6] increasingly complex, [7],[8] and with more women at high risk of breast cancer choosing to undergo risk-reducing surgery, such as bilateral prophylactic mastectomy,[9],[10] PICO 7Y is improving the delivery of therapy for what is currently an unmet need,” said Paolo Di Vincenzo, Smith & Nephew’s Senior Vice President Global Marketing of Advanced Wound Management. “PICO 7Y delivers effective therapy to two surgical wounds simultaneously with a unique patient friendly system, which we believe will help improve patient outcomes, patient management and health care professional efficiency across diverse clinical settings.” 

PICO 7Y is the latest addition to the PICO family of sNPWT products, which have revolutionised the use of negative pressure wound therapy by making a treatment, previously predominantly used in a hospital inpatient setting, available to a wider range of outpatients in a cost effective, portable solution.[11],[12] PICO has been shown to significantly reduce wound complications following breast reduction surgery compared with standard dressings.[13]* In a breast cancer study with patients undergoing therapeutic mammoplasty, PICO reduced the incidence of post-surgical wound dehiscence by 75% compared with standard care, thereby reducing the potential for delay in the commencement of adjuvant therapy.[14**] There is a growing body of literature supporting PICO as an effective prophylactic treatment option for surgical site infections including the recent publication of a Medtech Innovation Briefing from the UK National Institute for Health and Care Excellence (NICE)[15].

It was confirmed that PICO 7Y met all relevant regulatory European requirements on 21 August 2018. Regulatory clearance in the US is pending.

*Absolute difference of 5% (10 patients); p=0.004. **Reduction in wound breakdown: 24 patients; PICO 4.2%; standard dressings 16.7%. Number of patients too small to test for statistical significance.

 

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About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopaedic Reconstruction,Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit www.smith-nephew.com/pico7y, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce surgical site complications, please visit www.closertozero.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.

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.

◊ Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.  

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Notes

[1] Data on file. A volunteer trial to assess dressing performance of Palermo multisite vs Control. OR-DOF/42 2014.
[2] PICO 7Y lndicator activation test report. Internal Report. RD.18.074 v1. 2018.
[3] PICO 7Y Human Factors Summary. Internal Report. WMP/16/533/UEF/R15.2018.
[4] Smith & Nephew. 2018. PICO 7Y Device Noise Test Report. Internal Report RD.18.076 v2.
[5] Data on File Report – DS/17/701/R. Dec 2017 Acoustic Testing Report: Comparison of PICO™ 7 to PICO 1.6 Devices.
[6] International Society of Aesthetic Plastic Surgery. ISAPS statistics infographic for 2016. Available at:  https://www.isaps.org/wp-content/uploads/2017/10/GlobalStatistics.Infographic2016-1.pdf. Accessed 29 May 2018.
[7] Dietz J, Lundgren P, Veeramani A, et al. Autologous inferior dermal sling (autoderm) with concomitant skin-envelope reduction mastectomy: an excellent surgical choice for women with macromastia and clinically significant ptosis. Ann Surg Oncol. 2012;19:3282-3288.
[8] McCulley SJ and Macmillan RD. Planning and use of therapeutic mammoplasty – Nottingham approach. Br J Plast Surg 2005;58:889-901.
[9] Wong SM, Freedman RA, Sagara Y, Aydogan F, Barry WT, Golshan M. Growing use of contralateral prophylactic mastectomy despite no improvement in long-term survival for invasive breast cancer. Ann Surg. 2017;265:581–589.
[10] National Cancer Institute. Surgery to reduce the risk of breast cancer. Available at: https://www.cancer.gov/types/breast/risk-reducing-surgery-fact-sheet. Accessed 24 September 2018.
[11] Hurd, T. Evaluating the costs and benefits of innovations in chronic wound care products and practices. Ostomy Wound Management. 2013; Supplement(June):1–16. Available at: https://www.o-wm.com/pdf/SN-supp-june.pdf. Accessed 24 September 2018.
[12] Smith & Nephew. March 2018. Kendal PICO 7Y - pump weight and dimensions. Internal Report. DS.18.066.R.
[13] Galiano RD, Hudson D, Shin J, et al. Incisional negative pressure wound therapy for prevention of wound healing complications following reduction mammaplasty. Plast Reconstr Surg Glob Open 2018;6:e1560.
[14]  Holt R and Murphy J. PICOÔ incision closure in oncoplastic breast surgery: a case series. Br J Hosp Med 2015;76:217-223.
[15] NICE Medtech Innovation briefing (MIB149). PICO negative pressure wound therapy for closed surgical incision wounds. Published June 2018. Available at: https://www.nice.org.uk/advice/mib149. Accessed 24 September 2018.

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