Smith+Nephew's PICO™ 7 and PICO 14 Negative Pressure Wound Therapy Systems are the first systems indicated to aid in reducing the incidence of both deep and superficial incisional surgical site infections and dehiscence

Rhea-AI Summary

Smith+Nephew (LSE:SN, NYSE:SNN) announced FDA clearance for its PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy Systems. These systems are now indicated for closed surgical incisions to reduce the risk of superficial and deep surgical site infections (SSIs), post-operative seromas, and dehiscence. Over 500,000 patients in the U.S. experience SSIs annually, leading to 8,000 deaths. The PICO system has been used in about 2.3 million surgical cases over the last decade, proving effective in managing post-surgical complications.

Positive

• FDA clearance for PICO 7 and PICO 14 systems enhances marketability.
• Addressing high incidence of SSIs can lead to increased product adoption.
• Clinical studies indicate significant efficacy in reducing surgical complications.

Negative

• None.

LONDON, Jan. 24, 2022 /PRNewswire/ -- Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business, is pleased to announce new indications for use for its PICO 7 and PICO 14 Single Use Negative Pressure Wound Therapy (sNPWT) Systems. The U.S. Food and Drug Administration (FDA) cleared the systems for use on  closed surgical incisions, to aid in reducing the incidence of:

• Superficial and deep incisional surgical site infections (SSIs) for high risk patients in Class I and Class II wounds
• Post-operative seroma
• Dehiscence

The development of post-operative surgical site complications (SSCs), such as surgical wound dehiscence, are a substantial burden for patients and healthcare systems, globally¹. Postoperative wound dehiscence cases from the Nationwide Inpatient Sample demonstrate 9.6% excess mortality, 9.4 days of excess hospitalization and $40,323 in excess hospital charges relative to matched controls². In addition, it is estimated that 5% of all patients undergoing a surgical procedure will develop an SSI¹. In the U.S. alone, more than 500,000 patients are affected by SSIs each year, resulting in about 8,000 deaths annually³. SSIs are also the most common reason for readmission to the hospital, accounting for 19.5% of overall readmissions⁴. However, 60% of all SSIs are considered preventable². 

"As a high-volume elective hip and knee replacement surgeon, I am sending more patients home the same day with outpatient surgery," said Dr. Bashyal, Director of Outpatient Total Joints, NorthShore University Health System, Chicago, Illinois. "The PICO System has been a game changer in managing closed incisions in my practice by helping to reduce the incidence of wound complications, including drainage, seromas, and superficial infections."

As part of the process for FDA clearance of the PICO 7 and 14 sNPWT Systems, the clinical evidence was subject to rigorous review. Only the highest quality evidence was considered, such as randomized controlled trials (RCTs). Overall, twenty-five (25) studies enrolling 5,560 patients were included, spanning a variety of surgical specialties such as cesarean section, orthopedics and colorectal. By performing meta-analyses on these studies, the PICO 7 sNPWT System demonstrated statistical efficacy when compared to conventional dressings, including the reduction of the incidence of superficial and deep incisional SSIs for class I and class II wounds. The PICO System also reduced the odds of post-operative seroma and dehiscence.

Recently celebrating 10 years in clinical practice, PICO sNPWT has been used on an estimated 2.3 million surgical incisions, helping to prevent surgical site complications.^1,5 The PICO System has helped reduce hospital stays and spared healthcare systems the associated costs of nursing time and resourcesⱡ^1,6,7.

Additionally, the PICO 7Y System, which treats two wounds simultaneously, was also cleared by the FDA to aid in the reduction of the incidence of superficial incisional SSIs for high risk patients in Class I wounds, post-operative seroma and dehiscence. The PICO System is demonstrated to be effective for up to 7 days for aiding in reducing the incidence of surgical site infection.

To learn more about PICO sNPWT see www.possiblewithpico.com

For full product and safety information, please see the Instructions for Use.

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Dave Snyder	1-978-749-1440
Smith+Nephew

ⱡ Compared to standard of care

References

1. World Union of Wound Healing Societies (WUWHS), 2016. Closed surgical incision management: Understanding the role of NPWT. Wounds International.
2. Shanmugam, V. K., Fernandez, S. J., Evans, K. K., McNish, S., Banerjee, A. N., Couch, K. S., Mete, M., & Shara, N. (2015). Postoperative wound dehiscence: Predictors and associations. Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society, 23(2), 184–190. https://doi.org/10.1111/wrr.12268
3. Najjar PA, Smink DS. Prophylactic antibiotics and prevention of SSIs. Surg Clin N Am 2015;95(2):269-283.
4. Merkow RP, et al. Underlying reasons associated with hospital readmission following surgery in the United States. JAMA 2015;313(5):483-495.
5. DOF Smith+Nephew 2021. Assumptions on product channel split.
6. Dowsett C, Hampton K, Myers D, Styche T. Use of PICO to improve clinical and economic outcomes in hard-to-heal wounds. Wounds International. 2017;8(2):52-58
7. Saunders C, Nherera LM, Horner A, Trueman P. Single-Use negative-pressure wound therapy versus conventional dressings for closed surgical incisions: systematic literature review and meta-analysis. BJS Open. 2021;0(0):1 - 8.

About Smith+Nephew

Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist 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 18,000 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 $4.6 billion in 2020. 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.

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: risks related to the impact of COVID-19, such as the depth and longevity of its impact, government actions and other restrictive measures taken in response, material delays and cancellations of elective procedures, reduced procedure capacity at medical facilities, restricted access for sales representatives to medical facilities, or our ability to execute business continuity plans as a result of COVID-19; economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers (including, without limitation, as a result of COVID-19); 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 (including, without limitation, as a result of COVID-19); 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 organization 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.

PCEE5-34041-0122

 

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SOURCE Smith & Nephew plc

FAQ

What recent approval did Smith+Nephew receive for its PICO systems?

Smith+Nephew received FDA clearance for the PICO 7 and PICO 14 systems to reduce surgical site infections and other complications.

What are the indications for the PICO 7 and PICO 14 systems?

The systems are indicated for closed surgical incisions, aimed at reducing deep and superficial incisional surgical site infections, seromas, and dehiscence.

How many patients in the U.S. are affected by surgical site infections annually?

More than 500,000 patients are affected by surgical site infections in the U.S. each year.

What clinical evidence supports the efficacy of the PICO systems?

The efficacy of PICO systems is supported by 25 studies involving over 5,500 patients, demonstrating significant reductions in surgical complications.