AUSTIN, TX – March 25, 2019 – Johnson & Johnson Medical Devices Companies* today announced Ethicon** has launched a new global registry to collect and analyze real-world data on patients with soft tissue liver lesions ablated with the company’s NEUWAVE Microwave Ablation System. The company made the announcement here at the annual meeting of the Society of Interventional Radiology (SIR 2019).
The multicenter, observational registry will follow approximately 1,500 patients worldwide for a total of five years from the date of their first liver ablation procedure with the NEUWAVE System, a minimally invasive microwave ablation technology that uses heat transmitted through image-guided needle-like probes to destroy soft tissue lesions.
Real-world data will be collected from up to 30 centers throughout the world on the technical aspects of the procedure including ablation time under varying liver tissue and lesion conditions. Efficacy and other outcome data will also be documented and assessed at various time points over the course of the study.
“The goal of the registry is to systematically and comprehensively develop ablation parameter guidance for the microwave ablation of liver lesions with the NEUWAVE System,” said Dr. Paul Laeseke^, Interventional Radiologist, University of Wisconsin School of Medicine and Public Health, who consulted on the design of the registry. “Microwave ablation is an important treatment option that is increasingly being utilized throughout the world, and this data may provide new insights into factors that are critical for successful outcomes across a range of patients, clinical settings and health care providers. The registry will be an important contribution to our understanding of microwave ablation and support its further adoption.”
The registry will also include data from consenting patients enrolled in other Ethicon-sponsored studies on microwave liver ablation with the NEUWAVE System in Korea and China and a multicenter study that is evaluating the device using NEUWAVE’s Ablation Confirmation Software, which helps physicians identify ablation targets, assess appropriate probe placement and confirm the technical success of each procedure.
“Microwave is the fastest growing ablation modality1 and as this treatment grows, Ethicon is committed to working with clinicians throughout the world to generate robust clinical evidence for the innovative NEUWAVE Microwave Ablation System. This will help inform treatment decisions and improvements in procedural efficiency and patient outcomes,” said Piet Hinoul, Global Head Medical & Clinical Franchise Lead for Ethicon.
The NEUWAVE System, the microwave ablation market leader in the United States,2 is a minimally invasive system that enables physicians to effectively tailor ablations for lesions of varying shapes and sizes with consistency and control.3,4 Studies have shown microwave ablation has strong efficacy and a favorable complication profile. Most patients leave the hospital the same day with only a bandage at the probe insertion site.5
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, leveraging science and technology, to shape the future of health care. With unparalleled breadth, depth and reach in surgery, orthopaedics, vision and interventional solutions we are 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 NEUWAVE Microwave Ablation System. 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 Endo-Surgery, LLC, 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 31, 2017, 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 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.
* The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
** 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.
^ Dr. Paul Laeseke is a consultant for Ethicon
1. Millennium Research Group 2015.
2. DRG Data
3. Ex-vivo data available in probe Instructions For Use. See ex-vivo data available in probe Instructions For Use.
4. Laeseke et al. Multiple-Antenna Microwave Ablation: Spatially Distributing Power Improves Thermal Profiles and Reduces Invasiveness. Journal of Interventional Oncology. 2009; 2(2):105-112. Brace et al. Simultaneous Activation of Multiple Microwave Antennas Improves Circularity and Ablation Zone Volume Compared to Sequentially Overlapping Ablations. Presented at conference with accompanying poster, WCIO 2014.
5. J. Horn, et al, Percutaneous Microwave Ablation of Renal Tumors Using a Gas-Cooled 2.4-GHz Probe; Technique and Initial Results. Journal of Vascular Interventional Radiology 2014; 25:448-453