Real-World Medical Device Reports of SpaceOAR Hydrogel Spacer: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) Database
With respect to estimated device usage in the United States, overall device-related events and patient event rates for PEG hydrogel spacers consistently remained below 1%, with the majority having minimal or no reported clinical consequence.
Authors
- Lara Hathout (ORCID: https://orcid.org/0000-0003-3062-9793)
- Sirikan Rojanasarot (ORCID: https://orcid.org/0000-0003-2102-7520)
- Michael R. Folkert (ORCID: https://orcid.org/0000-0003-3062-9793)
- Yong Woon Shin (ORCID: https://orcid.org/0000-0001-7876-6178)
- Emmanuel Ezekekwu
Institutions
- Rutgers, The State University of New Jersey (US)
- University of Washington (US)
- Boston Scientific (United States) (US)
- University of Cincinnati Medical Center (US)
Publication Details
- Journal
- Advances in Radiation Oncology
- Published
- 2025-06-07
- DOI
- https://doi.org/10.1016/j.adro.2025.101824
- Citations
- 1
- Primary Topic
- Quality Function Deployment in Product Design
- Type
- article
- Field-Weighted Citation Impact
- 2.76
Funders
- University of Cincinnati
- Boston Scientific Corporation