Ethicon*, a Johnson & Johnson MedTech Company** has announced today the treatment of the first patient in North America in its 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 NEUWAVE™ FLEX Microwave Ablation System guided by the MONARCH® Platform. The study involves leading global thoracic oncology centers and is intended to enroll patients with oligometastatic (OML) tumors in the lung.
“We are extremely proud to have treated the first patients in North America in this exciting trial, which can be an important part of the future armamentarium for doctors treating lung cancer all over the world,” says Dr. Moishe Liberman, Thoracic Surgeon and Director of the Endoscopic Tracheobronchial and Esophageal Center at the CHUM Hospital in Montreal, Canada.i “The entire robotics, thoracic, radiology, anesthesia and research teams at the CHUM worked conjointly to make these first few cases a success for our patients. We are looking forward to treating more patients with this innovative technology in the near future.”
About OML disease to the lung
The lung is a common site for metastatic spread of solid organ cancers such as colorectal, kidney and sarcoma and impacts thousands of patients across North America. Systemic therapies are continuing to become more effective in treating patients with metastatic cancers. A subgroup of patients; however, have residual tumors in the lung and other organs that do not resolve despite those systemic treatments. This subgroup of patients is determined to have an intermediate state of advanced malignancy in the lung called OML disease for which managing physicians continue to seek additional minimally invasive and lung-sparing therapies.
“We are excited to now be able to perform this minimally invasive treatment for OML cancer patients in North America in the POWER study, which is the first of its kind to use precision robotic-assisted bronchoscopy to deliver targeted transbronchial microwave ablation for the treatment of metastatic tumors in the periphery of the lung,” explains Avrum Spira, MD, MSc, Global Head, Lung Cancer Initiative at Johnson & Johnson.*** “The treatment of the first patient in North America in the study by Dr. Liberman and the team at CHUM is another exciting step in our mission to bring novel treatment approaches to cancer patients and potentially change the trajectory of the leading causes of cancer mortality worldwide.”
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.
Ethicon is a global leader in soft tissue microwave ablation with the NEUWAVE™ System and in flexible endoluminal robotics with the MONARCH® Platform. The NEUWAVE™ microwave ablation technology provides a minimally invasive option for soft tissue lesions. The MONARCH® Platform provides improved reach into the periphery of the lung with continuous real-time vision, precision and control, and was the first robotic-assisted bronchoscopy system introduced in the United States. The NEUWAVE™ FLEX Microwave Ablation System incorporates the established core NEUWAVE™ microwave ablation technology into a long flexible probe combined with the continuous real-time vision, precision and control provided by the MONARCH® Platform.
- POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy); ClinicalTrials.gov Identifier: NCT05299606
- Dr. Liberman has been a consultant to Ethicon affiliates and has received support for clinical research from Ethicon affiliates in the past.
*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