CINCINNATI, OH – June 21, 2021 -- Ethicon*, part of the Johnson & Johnson Medical Devices Companies,** today announced the launch of the ENSEAL X1 Curved Jaw Tissue Sealer, a new advanced bipolar energy device that increases procedural efficiency1 and provided stronger sealing2 and better access to more tissue than LigaSure™ Maryland3. The device is indicated for colorectal, gynecological, bariatric surgery and thoracic procedures.
The ENSEAL X1 Curved Jaw is the first of several new advanced laparoscopic bipolar devices the company plans to launch in the coming months as it expands its extensive energy portfolio, which includes market-leading HARMONIC ultrasonic devices and MEGADYNE core electrosurgical tools.
Among the ENSEAL X1 Curved Jaw’s new features are separate seal and cut capabilities, a 360-degree continuous shaft rotation that enables easy access to targeted tissue4, and Ethicon’s Adaptive Tissue Technology, which enables the device to continuously sense changes in the condition of tissue and respond accordingly with the optimal amount of energy to minimize lateral thermal spread.5,6 These features, including improved ergonomics and a one-handed operation, combine to offer precision, a secure seal and a more intuitive and simplified use that may deliver greater efficiency in the operating room.7,8,9,10
“This is an intelligent and intuitive energy device that provides secure sealing and an ease of use that improves upon currently available advanced bipolar sealing devices,” said Steven McCarus, MD, Chief of GYN Surgery at AdventHealth Celebration.*** “It feels great in your hand, and I think it will make a real difference in procedures in terms of patient outcomes and procedural efficiency.”
Ethicon previously launched the ENSEAL X1 Large Jaw Tissue Sealer for vessel sealing in open surgical procedures and to provide better hemostasis, minimize thermal spread, and improve ergonomics than Medtronic’s LigaSure Impact. 11,12,13
“Ethicon is the only company with the expertise deep enough and the energy portfolio broad enough to offer tailored, proven and reliable product and service solutions that span virtually every energy modality, surgical specialty and procedure,” said Kate Masschelein, President, Ethicon. “We will continue to develop innovative solutions that leverage our decades of experience in surgery and our deep understanding of the science of tissue management, device-tissue interaction and OR safety to set new standards of performance in surgery.”
Ethicon, part of 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 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 www.ethicon.com.
About Johnson & Johnson Medical Devices Companies
As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics, vision, and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the ENSEAL X1 Curved Jaw Tissue Sealer. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Ethicon, Inc. the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
* Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. All other trademarks are the property of their respective owners.
** The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
*** Consultant to Ethicon
- ENSEAL X1 Curved Jaw Tissue Sealer can capture, seal, and transect a longer length of tissue per single activation due to a 16% (or 3.4mm) longer jaw (p < 0.001) and a 19% (or 3.5mm) longer cut length (p < 0.001) compared to LigaSure™ Maryland (LF1937). (145163-200630)
- In benchtop testing on porcine arteries, vessels sealed with ENSEAL X1 Curved Jaw had a 22% higher average burst pressure than vessels sealed with LigaSure™ Maryland (LF1937), (1055mmHg vs. 862mmHg, p < 0.001). (145079-200629)
- As compared to devices with less than 360 degree shaft rotation (099992-181108)
- Mean thermal spread measured via histology on porcine carotid arteries. (095310-200519)
- Preclinical testing on porcine carotids that measured mean max lateral thermal damage via histology (mean=1.57 mm). (062963-161108)
- In benchtop testing on 4-7mm porcine carotid arteries, average burst pressure was 1274 mmHg. (100001-181002)
- ENSEAL® X1 Curved Jaw Tissue Sealer can capture, seal, and transect a longer length of tissue per single activation due to a 16% (or 3.4mm) longer jaw (p < 0.001), a 40% (or 5.0mm) wider unbiased jaw aperture (p < 0.001) and a 19% (or 3.6mm) longer cut length (p < 0.001) compared to LigaSure™ Maryland (LF1937). (093774-190114)
- Preclinical test of distal tip bleeding (ENSEAL® X1 Large Jaw vs. Impact-LF4318) in thick porcine mesentery base (p=0.001). (062628-210224)
- Preclinical testing on porcine carotids (ENSEAL® vs. Impact-LF4318) that measured mean max lateral thermal damage via histology (p=0.005). (062746-180228)
- Versus LigaSure Impact with only 180º rotation. (062936-180228)
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
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