Innoblative has launched a groundbreaking device called SIRA™ RFA Electrosurgical Device (SIRA) for breast cancer patients.
This device has been granted breakthrough status by the US Food and Drug Administration (FDA).
The SIRA device is specifically designed for use in patients undergoing breast-conserving surgery (BCS), also known as lumpectomy.
Numerous long-term clinical trials have demonstrated the efficacy of radio-frequency (RF) ablation in reducing reoperations and potentially lowering the risk of local recurrence in breast cancer treatment. However, conventional RF devices are not intended for treating lumpectomy cavities and can result in inconsistent treatment depths and partial ablations.
In contrast, Innoblative's SIRA device features a unique spherical shape that enables circumferential transmission of RF energy throughout the entire cavity, resulting in reproducible ablation depths and ensuring a more consistent thermal effect.
The SIRA device is currently undergoing investigation for its application in breast-conserving surgery (BCS) and is not currently available for purchase in the United States.