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Smith & Nephew announces US launch of new PICO™ 7 Single Use Negative Pressure Wound Therapy System

PICO 7 US product image

12 December 2018

Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, is pleased to announce the US launch of the new PICO 7 Single Use Negative Pressure Wound Therapy System (sNPWT), which delivers clinical1* and cost effectiveness benefits2**, all the while supporting an improved patient experience3***.

Clinically, PICO 7 delivers a more efficient vacuum and superior leak management than the previous version4****, designed to support improved application on anatomically challenging areas where it is traditionally more difficult to achieve and maintain a seal. It also includes an industry-first dressing-full indicator, which is intended to help reduce unnecessary dressing changes and wastage.

For the patient, PICO 7 is more than 25% quieter than the previous version5*****, making it less intrusive, providing potential value when the patient is outside the home or sleeping. There is also a new user interface to simplify patient operation and a belt clip to improve portability.

Dr. Ravi K. Bashyal M.D, NorthShore University HealthSystem Medical Group, Director Outpatient  Hip and Knee Replacement Surgery, a PICO user, said: “PICO 7 leads the industry as the most innovative, adaptable, and easy to use portable negative pressure dressing, with robust clinical data to support improved clinical outcomes for our patients.”

PICO 7 is designed for patients at risk of wound complications, and has been shown to help minimize the risk of infection and/or dehiscence1*. It is suitable for use across hospital, outpatient and post-acute settings and approved for a number of indications, including closed surgical incisions and chronic wounds.

The PICO dressing, including a proprietary AIRLOCK™ Technology layer, uniformly and consistently delivers NPWT across a surgical incision or chronic wound and the surrounding zone of injury.6,7 This proprietary feature is designed to help reduce the risk of wound complications by reducing post-operative fluid, swelling and associated tension around a closed surgical incision compared with standard dressings.8,9 The combination of these actions helps reduce the risk of surgical wound dehiscence1* and surgical site infections (SSIs)1*, the two most common surgical site complications.

A recently published meta-analysis, of over 1800 patients, demonstrated a 58% reduction in SSIs using PICO prophylactically in closed surgical incisions compared with standard care, across multiple surgical specialities1*.

“With PICO and its proprietary dressing with the AIRLOCK technology layer, we revolutionized the use of negative pressure wound therapy, making a treatment previously predominantly used in a hospital inpatient setting available to a wider range of outpatients in a cost effective, portable solution,” said Paolo Di Vincenzo, Smith & Nephew’s Senior Vice President Global Marketing of Advanced Wound Management. “With PICO 7 we continue to demonstrate our commitment to healthcare professionals and patients’ evolving needs. This innovative sNPWT system delivers significant design improvements that contribute to improved patient outcomes, patient management and health care professional efficiency, keeping Smith & Nephew at the forefront of delivering innovative portable negative pressure solutions” added Paolo Di Vincenzo.

In June the UK’s National Institute for Health and Care Excellence (NICE) issued a Medtech innovation briefing for the use of PICO in closed surgical incisions to reduce surgical site complications10.

To read more about PICO, please see www.possiblewithpico.com.

To learn more about the meta analysis go to: http://www.smith-nephew.com/education/resources/literature/scientific-literature/2017/wound-evidence-pico/

Media

Dave Snyder
Smith & Nephew
+1 (978) 749-1440

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 our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

To learn more about what we do to help reduce the human and economic cost of wounds, 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.

Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office. © September 2018. 15863

*Meta-analysis included 10 RCT & 6 observational studies. Reduction in SSI (16 studies included): 1839 patients (2154 incisions); PICO 5.2%; control group 12.5%; p<0.0001.

** Calculations based on a 220-patient randomized controlled trial

*** A prospective cohort study of 52 wounds

**** In-vitro testing demonstrated PICO 7 was on average 9.89 dB quieter than PICO, p<0.001 95% confidence interval of 7.16 dB to 12.62 dB. n=22 and n=3

***** In-vitro testing demonstrated PICO 7 has a higher maximum leak rate than PICO, p<0.001 95% confidence interval of 20.3 to 26.7. n=6

 

References

1.  Strugala, V. and 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 (2017). DOI 10.1089/sur.2017.156
2. Nherera LM, Trueman P, Karlakki SL. Cost-effectiveness analysis of single-use negative pressure wound therapy dressings (sNPWT) to reduce surgical site complications (SSC) in routine primary hip and knee replacements. Wound Repair Regen. April 2017. doi:10.1111/wrr.12530
3. Dowsett et al 2017: Use of PICO to improve clinical and economic outcomes in hard to heal wounds. Wounds International 2017. 8(2), 52-58. A prospective cohort study of 52 wounds
4. Data on file report DS.17/666/R2. Comparison of PICO 1.6 and 2.1 Device Air Leak Tolerance. January 2018
5. Data on file report DS/17/701/R. Acoustic testing report: Comparison of PICO 7 to PICO 1.6 devices. December 2017
6. Data on File. DS/17/253/R. Project Opal PICO 7 System Stability Testing - Initial Time Point. October 2017
7. Malmsjö M et al. Biological effects of a disposable, canisterless Negative Pressure Wound Therapy system (in-vitro). Eplasty 2014; 14:e15
8. Selvaggi F et al., New Advances in Negative Pressure Wound Therapy (NPWT) for Surgical Wounds of Patients Affected with Crohn’s Disease. Surgical Technology International XXIV; 83- 89
9. Loveluck et al (2016) Biomechanical modelling of forces applied to closed incision during NPWT eplasty16e20
10. NICE Medtech Innovation briefing (MIB149), PICO negative pressure wound therapy for closed surgical incision wounds, published June 2018