Innoblative Discovered Novel SIRA RFA Electrosurgical Device

Innoblative discovered novel SIRA™ RFA Electrosurgical Device (SIRA) for the treatment of patients undergoing breast-conserving surgery (BCS) for breast cancer

The SIRA technology offers a promising advancement by allowing surgeons to address potential residual cancer in the lumpectomy cavity during the initial procedure.

The unique spherical shape of the SIRA device enables the circumferential delivery of radiofrequency (RF) energy throughout the entire cavity. This feature ensures consistent ablation depths, providing surgeons with greater confidence in achieving a reliable thermal effect.

By reducing the need for reoperations, the SIRA device aims to enhance the lumpectomy procedure and improve outcomes for breast cancer patients undergoing breast-conserving surgery (BCS).

The use of radiofrequency ablation in breast cancer treatment has been supported by several long-term clinical studies, which have demonstrated its ability to decrease the requirement for reoperations and potentially reduce local recurrence. However, conventional RF devices were not specifically designed to treat lumpectomy cavities, often resulting in varying treatment depths and incomplete ablations.

This designation acknowledges the potential of the SIRA technology to significantly impact the field of BCS for breast cancer. The development and introduction of this important technology hold great promise for improving the outcomes and experiences of cancer patients.

U.S. Food and Drug Administration (FDA) grants breakthrough designation for SIRA™ RFA Electrosurgical Device