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    1. Surgical/Critical Care
    2. Med-Surg Equipment

    New global registry will collect real-world data on liver lesions ablated with Ethicon device

    March 26, 2019

    Ethicon (Johnson & Johnson Medical Devices Companies) introduced a new global registry designed to collect and analyze real-world data on patients with soft tissue liver lesions ablated with the company's NEUWAVE Microwave Ablation System. The rollout was announced yesterday during 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 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.

    The NEUWAVE System enables physicians to effectively tailor ablations for lesions of varying shapes and sizes with consistency and control, according to research presented in an Ethicon press release. Studies have shown microwave ablation has strong efficacy and a favorable complication profile and that most patients are able to leave the hospital the same day with a minor surgical incision.