Novel Electrosurgical Device Could Be a Game-Changer for Breast Cancer Treatment

Breast cancer represents a significant health issue globally, affecting women in every country. After diagnosis, patients face challenging choices about their treatment paths. One common treatment, Breast Conservation Therapy (BCT), consists of breast-conserving surgery (BCS) followed by radiation therapy. However, BCS often requires re-operation—nearly 20% of patients need additional surgery soon after their initial procedure to remove remaining cancer cells. Furthermore, the accompanying radiation therapy involves frequent sessions over weeks or months, which can cause various side effects. Consequently, many patients choose mastectomy, a more radical procedure, to circumvent these issues and reduce the fear of cancer recurrence. Now, a novel breakthrough device allows surgeons to address potential residual cancer in the lumpectomy cavity at the time of the initial procedure, eliminating the need for patients to undergo subsequent radiation therapy or reoperation.

Radiofrequency (RF) ablation has been demonstrated in several long-term clinical trials to reduce the need for reoperations and may also lower the risk of local cancer recurrence. Traditional RF ablation tools, however, are not specifically designed for use in lumpectomy cavities, leading to uneven treatment depths and incomplete ablations. The SIRA RFA electrosurgical device from Innoblative Designs (Chicago, IL, USA) is designed for the intraoperative coagulation and ablation of soft tissue, targeting residual cancer post-lumpectomy with a single-use disposable applicator. This device works in combination with a RF electrosurgical generator to effectively ablate the target tissue.

The SIRA device’s electrode with a distinctive spherical shape evenly distributes RF energy throughout the lumpectomy cavity, ensuring consistent ablation depths and reliable thermal effects. The device has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) as well as CE Mark approval. Innoblative Designs has also conducted its first-in-human clinical trials, with successful treatment administered to a 64-year-old woman diagnosed with stage II luminal A breast cancer.

"This is an exciting time as Innoblative transitions to a commercial company. We look forward to expanding upon this early clinical experience which brings us one step closer to delivering this meaningful technology to breast cancer patients," said Richard Stark, CEO of Innoblative.

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