NEXTBIOMEDICAL Secures the US FDA’s IDE Approval of Nexsphere-F to Use it in Genicular Artery Embolization (GAE) for Knee Osteoarthritis
Shots:
- The US FDA has granted IDE approval to initiate RESORB clinical evaluation of Nexsphere-F for knee osteoarthritis. It is CE-MDD approved for arthritis embolization & has shown superior efficacy in various musculoskeletal embolization cases across Asia & the EU
- RESORB study will evaluate the efficacy of Nexsphere-F to ease pain & improve mobility in knee osteoarthritis patients, to be recruited in leading healthcare institutions across the US
- Nexsphere-F is a fast-resorbable hydrophilic microsphere, injected with a contrast medium, for endovascular embolization. It swells to temporarily block target blood vessels for promoting therapeutic outcomes & are fully resorbed to ensure biocompatibility
Ref: Prnewswire | Image: NEXTBIOMEDICAL
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