Devices

Workshop on Transbronchoscopic Thermal Ablation Devices

FDA has announced a 4/5-6 virtual public workshop entitled “Study Design Considerations for Transbronchoscopic Thermal Ablation (TTA) Devices for the Treatment of Oligometastases to the Lung (OML).” The workshop is intended to provide a forum for stakeholders to share information so FDA can develop appropriate regulatory review approaches to ensure the safety and effectiveness of this novel local therapy for treating OML.

“Earlier diagnosis and improved treatment of primary tumors across various anatomical sites has led to the increased need for clinical management strategies for patients presenting with OML,” an agency notice says. Current treatments include systemic drug therapy, surgical metastasectomy, stereotactic body radiation therapy, or CT-guided percutaneous thermal ablation. “Recently, the transbronchoscopic approach for catheter delivery of thermal ablation to lung oligometastases has been proposed as a less invasive treatment that may be associated with lower morbidity,” it says. “However, there is currently a lack of consensus on the role of local therapy in the management of OML and how the safety and effectiveness of new local therapies such as TTA should be evaluated.”

FDA says the workshop will cover disease definitions, appropriate patient population identification, and key study design considerations including the most appropriate safety and effectiveness endpoints, control arms, duration of follow-up, and the role of surrogate endpoints (e.g. local control) in evaluating device effectiveness.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome