Innoblative Secures the US FDA’s IDE Approval of SIRA Electrosurgical Device for Breast Cancer Patients
Shots:
- The US FDA has granted IDE approval to initiate US feasibility study of SIRA radiofrequency ablation (RFA) electrosurgical device for pts undergoing breast-conservation surgery (BCS)
- SIRA device is a single-use applicator designed to deliver circumferential RFA to the post-lumpectomy cavity during breast-conserving surgery to provide consistent ablation depth & increased confidence in margin treatment compared to conventional RF systems
- SIRA device is designed to reduce positive margin rates, minimize BCS reoperations, & provide one-time, non-ionizing alternative to radiation therapy for eligible pts
Ref: Innoblative | Image: Innoblative
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