New Data Presented at CIRSE Expands Support for The Use of NEUWAVE™ Ablation Confirmation Software to Help Improve Microwave Ablation Procedure Outcomes
CINCINNATI – September 30, 2020 – A new study found the use of the NEUWAVE™ System with Ablation Confirmation software demonstrated improved procedural outcomes during liver tumor ablation procedures. In this study, the information provided by the NEUWAVE Ablation Confirmation software resulted in probe repositioning in 20-23% of the procedures, 100% technical success and improved overall procedural outcomes.1
The study was published online in mid-September as part of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2020 Summit. The study was sponsored by Ethicon*, a Johnson & Johnson Medical Devices** Company, and the manufacturer of the NEUWAVE Microwave Ablation System, a minimally invasive technology that uses heat transmitted through image-guided needle-like probes to destroy targeted soft tissue lesions in the liver, kidneys and lungs. Read the study summary for more details.
“The NEUWAVE Ablation Confirmation helps improve precision and accuracy in ablation procedures, which is critical to achieving technical success. I believe this software will become standard practice as we seek to improve outcomes,” said Paul Laeseke, MD, PhD4, study co-author and an interventional radiologist at the University of Wisconsin - Madison.
The NEUWAVE Ablation Confirmation software is the only integrated in-procedure confirmation software on the market. The software assists physicians by improving visualization throughout the procedure and by helping define and lock target tumor volume, evaluate the exact proximity of the probe to the target and verify technical success to ensure full tumor and margin coverage.
Previously, researchers from Memorial Sloan Kettering Cancer Center presented studies at both annual meetings for the Society of Interventional Oncology (SIO) and the Society of Interventional Radiology (SIR) highlighting their experience with the NEUWAVE Ablation Confirmation software. The studies demonstrated the software was superior at detecting margins of 5mm or less (38.5% detected) in ablated tumors versus standard CT scans alone (0% detected). In addition, the study found that the software had high sensitivity and specificity for predicting local tumor progression (100% / 92.3%).2
The NEUWAVE System is already the leader in Microwave Ablation in the United States and is growing rapidly throughout Europe and Asia.3 The addition of NEUWAVE Ablation Confirmation software is predicted to accelerate adoption.
With the promising results shown in this emerging evidence, Ethicon continues to invest in evidence to support the NEUWAVE Microwave Ablation System. Last year, the company launched a prospective study on NEUWAVE Ablation Confirmation as well as a global registry to collect and analyze real-world data on patients with soft tissue liver lesions ablated with the NEUWAVE System.
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 worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
About Johnson & Johnson Medical Devices Companies
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.
*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, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.
1, Lescher J. et al. Effect of Ablation Confirmation Software on Microwave Ablation Efficacy and Outcomes. Presented at CIRSE 2020 Annual Conference
2. Kamarinos, NV, et al. 3D Assessment of Ablation Zone Margins with NeuWave Ablation Confirmation (AC) Software: A Feasibility Study. Abstract presented at the Society of Interventional Oncology Annual Meeting, 31 January – 3, February 2020, New Orleans, Louisiana, USA. Kamarinos, NV, et al. Three-dimensional assessment of the ablation zone margins with the NeuWave Ablation Confirmation software: a feasibility study. Journal of Vascular and Interventional Radiology 31 (3): S216. 2020
3. Millennium Research Group 2019. Interventional Oncology Devices.
4. Paul Laeseke, MD, PhD is a paid consultant for Ethicon.
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This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding NeuWave. 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 Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; 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 29, 2019, 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. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.