Chicago-based Innoblative Designs develops the SIRA RFA electrosurgical device, which holds FDA breakthrough device designation. It designed SIRA for use in breast cancer patients undergoing BCS (lumpectomy). SIRA uses radiofrequency ablation (RFA) through a unique spherical shape that circumferentially delivers RF energy. It delivers this energy to the entire cavity and yields reproducible action depths.
Dr. Cem Yilmaz, a breast surgeon and founding director of the Istanbul Oncology Hospital in Istanbul, Turkey, performed the first case. Yilmaz successfully treated a 64-year-old patient with stage II luminal A breast cancer.
“It was extremely easy to use, and I was able to completely ablate the cavity post-lumpectomy without complications. This is incredibly exciting as it allowed me to easily address residual cancer in the surrounding tissue at the time of the initial procedure, eliminating the need for my patient to undergo subsequent radiation therapy or reoperations,” Yilmaz said in a news release. “I believe this will be a game-changer with the potential to make breast conservation surgery a more palatable option for patients.”
Innoblative says RF ablation can reduce reoperations and may reduce local recurrence in breast cancer treatments. However, conventional RF devices aren’t optimized to treat lumpectomy cavities. Using those devices can lead to variable treatment depths and incomplete ablations. That’s where SIRA could come in.
“This is an exciting time as Innoblative transitions to a commercial company,” Innoblative CEO Richard Stark said. “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.”
