Innoblative’s SIRA RFA Electrosurgical Device Receives a Breakthrough Device Designation from the US FDA for Breast Cancer Treatment
- The company received a Breakthrough Device Designation (BDD) from the US FDA for its SIR RFA electrosurgical device to be used in patients with breast cancer undergoing BCS (lumpectomy)
- In order to produce a consistent thermal effect, the electrosurgical device uses radiofrequency ablation (RFA) through a spherical shape that circumferentially delivers RF energy to the whole cavity
- In multiple long-term clinical studies, RFA has depicted the potential to reduce reoperation & local recurrence in breast cancer treatment. Additionally, Innoblative expects to present the data based on which it received the BDD at the ASBrS 2023
Ref: PR Newswire | Image: Innoblative
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