Real-World Medical Device Reports of SpaceOAR Hydrogel Spacer: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) Database

Purpose: Increasingly, polyethylene glycol (PEG) hydrogel spacers are being used to help reduce rectal toxicity in men undergoing radiation therapy for prostate cancer. Device-related issues and patient event rates from the Manufacturer and User Facility Device Experience (MAUDE) were assessed to co...

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Hauptverfasser: Lara Hathout, MD, Young Eun Shin, PharmD, Sirikan Rojanasarot, PhD, Emmanuel Ezekekwu, PhD, Danielle Vannan, PhD, Michael R. Folkert, MD, PhD
Format: Artigo
Sprache:Inglês
Veröffentlicht: Elsevier 2025-12-01
Schriftenreihe:Advances in Radiation Oncology
Online Zugang:http://www.sciencedirect.com/science/article/pii/S2452109425001113
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