ETHICON LAUNCHES NEW MEGADYNE™ MEGA SOFT™ REUSABLE PATIENT RETURN ELECTRODE

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New MEGADYNE™ MEGA SOFT™ Universal Plus – a versatile and easy to use patient return electrode1, designed to protect skin by eliminating adhesives and incorporating pressure reduction pad2,ii.

ETHICON*, part of Johnson & Johnson Medical Devices Companies**, today announced the launch of a new product in its MEGADYNE™ MEGA SOFT™ portfolio of reusable patient return electrodes, which have been used in over 100 million procedures worldwide3.

The MEGADYNE™ MEGA SOFT™ Universal Plus Reusable Patient Return Electrode is a lightweight pressure reduction pad4,V, designed with more cushion to increase patient comfort5,i, and enhance pressure reduction6,i. Unlike traditional single-use adhesive patient return electrodes, MEGA SOFT™ is environmentally friendly7,ii and eliminates adhesive-related injuries8.

“We’re really proud to be launching the new MEGA SOFT™ Universal Plus in our Energy portfolio”, stated Said Haddad, Vice President ETHICON, EMEA. “This innovative device once again highlights our relentless aim to bring together science, people, technology and the ideas needed to profoundly change the trajectory of health for humanity. The new MEGA SOFT™ Universal Plus enables us to contribute to enhancing patient protection and environmental sustainability. In addition, it allows us to offer medical professionals the best-in-class tools and improve the standard of care in electrosurgery, which is undoubtedly one the most widely used surgical technologies today.” Up to 85% of all surgical procedures utilise electrosurgery9 which often involves a patient return electrode being directly applied onto the patient’s skin. However, electrosurgery-induced injuries may occur in up to five cases per 1,000 operations10. Most adverse events related to electrosurgery are pad site burns, which occur when the pad is applied incorrectly11, and can leave patients with unpleasant scars or more serious injuries10. MEGA SOFT™ Universal Plus is designed to eliminate this risk as it does not require direct contact with the patient. The pad is placed on the operating table, covered with a sheet, and the patient is then positioned on top of it. MEGA SOFT™ patient return electrodes eliminate the need for skin preparation14 and can be used for any size patient12,iii, in a wide variety of electrosurgical procedures1.

Patients undergoing surgery are particularly vulnerable to pressure injuries, with studies reporting incidence rates as high as 57%13. These injuries can be detrimental for the patient, both clinically and emotionally, and increase costs for the hospital. MEGA SOFT™ Universal Plus was designed with more cushion to increase patient comfort5,i and to decrease pressure6,i.

The pads are reusable for up to 24 months7,ii which reduces waste7,ii, and are compatible with most major brands of isolated electrosurgical generators15,iv.

For further information about the products, visit https://bit.ly/2lKszpK.

About Ethicon

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and adjunctive hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit https://www.ethicon.com/emea/

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

© Ethicon Endo-Surgery (Europe) GmbH 2019, 121638-190826 EMEA

CONTACTS
Chiara Antoniucci
Office: + 39 06 9119 4064
[email protected]

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* Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. **Comprising the surgery, orthopaedics, and interventional solutions businesses within the Johnson & Johnson’s Medical Devices segment
i Compared to MEGA SOFTTM Universal return electrode
ii Compared to traditional “sticky” patient return electrode
iii As per the IFU, the device is intended to be used up to 24 months as a reusable patient return electrode for patients from .35 kg (0.8lb) and up (no maximum restriction)
iv Per internal research
v Compared to MEGA SOFTTM return electrode

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1 Ethicon, 28022018, Universal Plus Equivalency Memo, Feb 2018, Data on File (115393-190529).
2 Ethicon, 28022018, Universal Plus Equivalency Memo, Feb 2018, Data on File. As per Instructions For Use. (115386‐190529).
3 Ethicon, 07082019, MegaSoft Sales and Procedures Calculation 2019, Aug 2019, Data on File (117766‐190702).
4 Ethicon, ENG‐RPT‐406, Verification Testing I, Universal Mega Soft, Oct 2013, Data on File. Ethicon, 28022018, Universal Plus Equivalency Memo, Feb 2018, Data on File. Ethicon, 31072019, Megasoft Pad Weights Memo, July 2019, Data on File. (115403-190529).
5 Ethicon, 28022018, Universal Plus Equivalency Memo, Feb 2018, Data on File (116660-190614).
6 Ethicon, 28022018, Universal Plus Equivalency Memo, Feb 2018, Data on File (116652‐190614).
7 As per Instructions for Use. (116789‐190617).
8 Ethicon, 28022018, Universal Plus Equivalency Memo, Feb 2018, Data on File. As per instructions for Use. (116780‐190617).
9 Medicines and Healthcare products Regulatory Agency. High Power electrosurgery review 2004. http://www.cedar.wales.nhs.uk/sitesplus/documents/1091/04080%20High%20Power%20electrosurgery%20review%202004.pdf. Accessed August 20, 2019.
10 Demircin S, Aslan F, Mustafa K, Atilgan M. Medicolegal aspects of surgical diathermy burns: A case report and review of the literature. Rom J Leg Med. 2013;21:173-176.
11 National Institute for Health and Care Excellence. Mega Soft Patient Return Electrode for use during monopolar electrosurgery 2012. https://www.nice.org.uk/guidance/mtg11/chapter/2-The-technology. Accessed August 20, 2019.
12 Ethicon, 28022018, Universal Plus Equivalency Memo, Feb 2018, Data on File. As per Instructions for Use. (115396‐190529).
13 Chen HL, Chen XY, Wu J. The incidence of pressure ulcers in surgical patients of the last 5 years: a systematic review. Wounds. 2012;24(9):234–241.
14 As per Instructions for Use. (114181‐190514).
15 Ethicon, 14062017, Generator Compatibility Chart, June 2017, Data on File. Ethicon, 28022018, Universal Plus Equivalency Memo, Feb 2018, Data on File. (117784‐190702).