LONDON, Sept. 10, 2019 /PRNewswire/ — Smith+Nephew (LSE: SN,NYSE: SNN), the global medical technology business, is pleased to announce the US launch of the new PICO 7Y Single Use Negative Pressure Wound Therapy System (sNPWT) with AIRLOCK™ Technology. This is the first PICO sNPWT pump to include an innovative integrated Y connector, enabling the utilization of two dressings concurrently from one pump, allowing for two wounds or incisions to be addressed simultaneously. PICO 7Y is appropriate for use on a variety of wound types such as closed surgical incisions, chronic and acute wounds.

The PICO 7Y sNPWT kit includes two large multisite dressings with extended soft port, designed to conform to complex anatomies.1 It is particularly suited for use on multiple wounds (for example breast procedures). The PICO 7Y pump also includes a check dressing indicator, which is intended to reduce unnecessary dressing changes and waste2,3, and is also 23% quieter than the first generation PICO,4,5 making it less intrusive for patients.

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.6,7 This unique feature is designed to help reduce the risk of wound complications by reducing post-operative fluid8,9 and tension*10 around a closed surgical incision, when compared with standard dressings. The combination of these actions helps reduce the risk of surgical wound dehiscence11 and surgical site infections11, the two most common surgical site complications. In a recent meta-analysis of 16 studies—comprising over 2,000 incisions across multiple surgical specialties—prophylactic use of PICO on closed surgical incisions significantly reduced surgical site infections by 58%, length of hospital stay by one half a day and wound dehiscence by 26.4% as compared to standard of care.12

“PICO 7Y is the latest addition to the PICO family of sNPWT products, which have revolutionized 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.13,14” said Ryan Frank, Vice President of US Marketing, Advanced Wound Management. The ability to treat two wounds simultaneously makes PICO 7Y ideal for procedures such as breast surgeries. “With breast surgical procedures becoming more frequent,15 increasingly complex,16,17 and with more women at high risk of breast cancer choosing to undergo risk-reducing surgery such as bilateral prophylactic mastectomy,18,19 PICO 7Y is improving the delivery of therapy for what is currently an unmet need.”

PICO™ sNPWT has a strong evidence base with 103 published papers of which 21 are published RCTs and 65 are unique clinical studies.20,21

To learn more about PICO 7Y please see www.possiblewithpico.com/introduction/pico7y

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.

* as demonstrated in biomechanical modelling
† 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.

References

  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. Smith & Nephew October 2017. Project Opal PICO 7 System Stability Testing, Initial Time Point. Internal Report. DS/17/253/R.
  7. Malmsjö M, Huddleston, E., and Martin, R., .Biological Effects of a Disposable, Canisterless Negative Pressure Wound Therapy System. ePlasty. 2014;14.
  8. 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.
  9. 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.
  10. 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.
  11. 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
  12. Strugala, V., Martin, R. Meta-analysis of comparative trials evaluating a prophylactic single-use negative pressure wound therapy system for the prevention of surgical site complications. Surgical Infections, Vol. 18, No. 00, 2017.
  13. 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.
  14. Smith & Nephew. March 2018. Kendal PICO 7Y – pump weight and dimensions. Internal Report. DS.18.066.R.
  15. 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.
  16. 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.
  17. McCulley SJ and Macmillan RD. Planning and use of therapeutic mammoplasty – Nottinghamapproach. Br J Plast Surg 2005;58:889-901.
  18. 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.
  19. Holt R and Murphy J. PICOÔ incision closure in oncoplastic breast surgery: a case series. Br J Hosp Med 2015;76:217-223.
  20. Smith & Nephew. Analysis by Dr Vicki Strugala. January 2019.
  21. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A Prospective, Randomized, Controlled Clinical Trial on the Efficacy of a Single‐use Negative Pressure Wound Therapy System, Compared to Traditional Negative Pressure Wound Therapy in the Treatment of Chronic Ulcers of the Lower Extremities. Wound Rep Regen. 2019. [Epub ahead of print]

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 16,000+ 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 $4.9 billion in 2018. 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 TwitterLinkedInInstagram or Facebook.

To learn more about what we do to help reduce 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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SOURCE: Smith & Nephew, PR Newswire, 10th September 2019

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Andrew Dubowski

Author Andrew Dubowski

Head of International Business Development

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