Medical device company Innoblative Designs has announced the successful first-in-human use of its SIRA device for breast cancer treatment.
The procedure was performed on a 64-year-old patient with stage II breast cancer in Istanbul, Turkey.
The SIRA RFA Electrosurgical Device is designed to improve outcomes for breast-conserving surgery (BCS) candidates.
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It offers a single-use, disposable applicator tailored for intraoperative soft tissue ablation, potentially eliminating residual cancer post-lumpectomy.
Istanbul Oncology Hospital founding director and breast surgeon Dr Cem Yilmaz carried out the lumpectomy procedure using the SIRA device.
Yilmaz said: “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. I believe this will be a game-changer with the potential to make breast conservation surgery a more palatable option for patients.”
With a spherical shape, the device’s electrode delivers radiofrequency energy circumferentially, ensuring consistent ablation depths and a reproducible thermal effect.
Innoblative CEO Richard Stark said: “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.”
Clinical studies have demonstrated that RF ablation can reduce reoperations and potentially cut local recurrence rates in breast cancer treatment.
The SIRA device received breakthrough designation from the US Food and Drug Administration for BCS use, last year, although it is not yet commercially available in the US for this purpose.
