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Pulmonary Artery Branch Sealing with Ultrasonic Energy Device Shows Promise in Minimally Invasive Lung Cancer International Clinical Trial
TORONTO – May 6, 2019 – In the first international clinical trial to use advanced energy technology in video-assisted thoracoscopic surgery (VATS) lobectomy, a minimally invasive surgery for lung cancer, “HARMONIC ACE+7, an ultrasonic energy device, was shown to be safe and effective for pulmonary artery (PA) branch sealing in vessels of 7mm or less”, investigators concluded. The research, which was funded by Ethicon*, part of Johnson & Johnson Medical Devices Companies,** and the manufacturer of the device, was presented at a late-breaking clinical trial session here at the American Association for Thoracic Surgery (AATS) Annual Meeting.
The multicenter clinical trial is the latest from lead investigator Moishe Liberman, MD, PhD, a minimally invasive thoracic surgeon at Centre Hospitalier de l'Université de Montréal (CHUM) in Canada, has been studying the use of the HARMONIC technology in VATS lobectomies with a goal of making the approach safer, easier and more reproducible, since 2014.
“The technical difficulty of VATS lobectomy is directly related to pulmonary artery branch manipulation and is one of the main reasons many thoracic surgeons are reluctant to adopt the minimally invasive procedure,” said Dr. Liberman^. “Hand-held energy devices have the potential to make it less difficult and diminish the risk of pulmonary artery injury. With appropriate training, the use of an ultrasonic vessel-sealing device is a reasonable alternative to endostaplers for PA branches of 7mm or less.”
The study included 150 patients from the United States, United Kingdom and Canada who had 139 lobectomies and 11 segmentectomies. A total of 424 PA branches were divided -- 239 with the HARMONIC ACE+7, 181 with endostaplers, and 4 with endoscopic clips. The mean and median PA diameters were 4.7mm/5mm, 10.3mm/10mm, and 6.5mm/6.5mm for each method, respectively. Successful vessel sealing was observed with 98.7% of the PA branches divided with HARMONIC ACE+7 and 97.8% of those divided with endostaplers (p=0.47). Among the patients with seal failures, one in the ultrasonic energy group required conversion to thoracotomy for vascular repair. There were no reports of postoperative bleeding and no deaths with any sealing method at 30 days.
“This is the most robust clinical trial to date on the potential use of ultrasonic energy for pulmonary artery branch sealing in VATS,” said Edmund Kassis, MD, Senior Medical Director, Thoracic Surgery, Ethicon. “Ethicon will continue to invest in generating evidence on our advanced energy portfolio, which is the most comprehensive in the world1, to validate our technologies and bring the benefits of less tissue damage2 with a goal of faster healing for more patients across the globe.”
According to the American Cancer Society, surgeons are increasingly treating early-stage lung cancers with VATS. In the procedure, a thin tube with a tiny video camera attached is placed through a small incision in
the side of the chest. One or two other small incisions are made for the insertion of surgical instruments that enable the surgeon to remove a diseased lobe or section of the lung. Because only small incisions are required, there is usually less pain after surgery and a shorter hospital stay compared to a traditional lobectomy or thoracotomy, where the chest is opened with a large incision.3
Ethicon, a proven leader in advanced energy, with devices used in approximately 24 million procedures worldwide4, provides intelligent energy solutions with the primary goal of helping patients heal faster. Our focus is to optimize the use of energy to do less tissue damage, advance operating room safety to minimize risks, and partner with our customers to create a healthier health system. Ethicon offers a comprehensive energy portfolio with our HARMONIC ultrasonic, ENSEAL advanced bipolar and MEGADYNE core electrosurgical portfolios to ensure surgeons have the right energy tool for the surgical jobs that are core to their open and laparoscopic procedures.
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.
* 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.
^ Moishe Liberman, MD, PhD is a consultant for Ethicon
- Upon review of product catalogs and websites (Advanced Energy, Core Energy, Surgical Smoke Evacuation) for the respective manufacturers: Medtronic, Olympus, Intuitive Surgical, Conmed. Ethicon (2017). (C2598)
- In bench-top test on 3‐7 mm porcine carotids that compared electrical energy with efficiency losses subtracted. HARMONIC ACE®+7 Advanced Hemostasis mode (55 Joules) versus LigaSure™ 5mm Blunt Tip (LF1537) at default 2 Green Bars (102 Joules) (p<0.001). As compared to HARMONIC® devices without Adaptive Tissue Technology. (C2871)
- Internal global sales data as of June 2016