Innoblative Designs has received Investigational Device Exemption approval from the U.S. Food and Drug Administration. This regulatory milestone allows the company to begin a feasibility study in the United States to assess the safety and effectiveness of its SIRA® RFA Electrosurgical Device in patients undergoing breast-conserving surgery (BCS).
The SIRA device is designed to be used during the initial lumpectomy procedure to treat residual cancerous tissue that may remain after tumour removal. The technology offers a potential alternative to follow-up radiation therapy or further surgical interventions.
The device is a single-use, disposable applicator developed for intraoperative radiofrequency ablation within the post-lumpectomy cavity. Its spherical shape enables consistent, circumferential RF energy delivery, which helps ensure even treatment around the cavity. This uniform energy application is intended to improve the chances of completely treating the surgical margins, which are areas where cancer may still be present.
RF ablation has already demonstrated, through several long-term clinical studies, the potential to reduce repeat surgeries and lower the risk of local cancer recurrence. However, existing RF devices are not tailored specifically for breast cancer treatment and may lead to uneven results. The SIRA device addresses this gap by aiming to provide consistent treatment depths and minimise the number of reoperations, while also offering a non-ionising alternative to traditional radiation therapy.
The IDE approval marks a pivotal step for Innoblative's SIRA® RFA device in advancing breast cancer treatment. By enabling precise, intraoperative RF ablation, it offers a promising alternative to radiation and repeat surgeries.
