Ethicon*, a Johnson & Johnson MedTech Company**, has announced the treatment of the first patient in its latest Investigational Device Exemption (IDE) clinical trial, the POWER1 study. This prospective, multicenter, single-arm study is intended to demonstrate the safety and effectiveness of transbronchial microwave ablation using the NEUWAVETM FLEX Microwave Ablation System guided by the MONARCH® Platform. The study, involving leading lung centers from around the world, is intended to enroll patients with oligometastatic tumors.
“The purpose of the POWER study is to demonstrate endobronchial microwave ablation as non-invasive and lung sparing with the latest advances in robotic bronchoscopy to help provide visualization and access to the airways,” explained Dr. Calvin Ng, Professor of Thoracic Surgery at Prince of Wales Hospital, The Chinese University of Hong Kong, and one of the lead study investigators.‡ “This approach may represent an important next-generation treatment option for lung tumors –minimizing the impact of surgery for patients and allowing for more rapid recovery. On behalf of the POWER study global investigators, we look forward to serving the patients who will participate in this trial and sharing the data and results in the future.”
Ethicon announced the grant of the Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for transbronchial microwave ablation technology using robotic-assisted bronchoscopy in July 2020. The Breakthrough Devices Program is a voluntary program for certain medical devices that provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of this program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for Premarket Approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.
1 POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy); ClinicalTrials.gov Identifier: NCT05299606
‡ Dr. Ng is an active consultant to Johnson & Johnson and receives support for clinical research from Ethicon.
*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.
**Johnson & Johnson MedTech comprises the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson.
*** The legal entity of the Lung Cancer Initiative at Johnson & Johnson is Johnson & Johnson Enterprise Innovation, Inc.
Source: Johnson & Johnson