FDA Grants IDE to Electrosurgical Device For Breast-Conservation Surgery

A US feasibility test to evaluate the safety and efficacy of the SIRA RFA Electrosurgical Device in patients who require breast-conservation surgery will be conducted in the future.

The FDA has approved the Investigational Device Exemption application for the SIRA™ RFA Electrosurgical Device in patients with breast cancer undergoing breast-conservation surgery, opening a path for the launch of a US feasibility study, according to a press release from the creator, Innoblative Designs.1

Currently, the SIRA device is investigational for use in breast-conservation surgery in the US.

The SIRA device utilizes a “unique” spherical design to operate as a single-use, disposable applicator for the intraoperative ablation of the post-lumpectomy cavity during surgery. It delivers radiofrequency energy, yielding reproducible depths of ablation to the entire cavity. The device is intended to give a surgeon greater confidence that the margins have been treated during surgery.

The developers noted that the goals of the SIRA device are to reduce positive margin rates, reduce breast-conservation surgery reoperations, and provide a one-time non-ionizing therapeutic alternative to radiation therapy in select patients. The device may hold the potential to improve patient care and reduce healthcare costs.

Previously, in April 2023, the SIRA device was granted breakthrough device designation by the FDA.2

“The SIRA device, specifically designed as an adjunct to [breast-conservation surgery], addresses residual cancer in surrounding tissue at the time of the initial lumpectomy procedure. The technology provides a more palatable option for patients and aims to eliminate the need for subsequent radiation therapy or reoperations,” commented Richard Stark, chief executive officer of Innoblative.1 “We are thrilled to have secured [Investigational Device Exemption] approval, a significant milestone for the company and a testament to the team’s hard work and dedication. We look forward to initiating the US feasibility study to further validate our technology, which we believe will be a game-changer for patients with breast cancer.”

The US feasibility study will be set to evaluate the safety and efficacy of the SIRA RFA Electrosurgical Device in patients undergoing breast-conservation surgery.

In July 2024, the company announced that a 64-year-old patient in Istanbul, Turkey, with stage II breast cancer, was treated with the SIRA device, marking them the first to receive such treatment.3

The treating surgeon, Cem Yilmaz, MD, 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.”

The prospective, phase 2 ABLATE I study demonstrated that radiofrequency ablation after breast lumpectomy may reduce the need for re-excision in patients with breast cancer who have close or focal positive margins.4

Additionally, breast-conservation surgery is generally associated with high rates of re-operation.5 A retrospective cohort study showed that in patients with commercial insurance, the reoperation rate was 21.1% vs 14.9% in patients with Medicare; the mean health care costs at 1 year of follow-up from surgery were $95,165 and $36,313, respectively. In both groups of patients, the rate of reoperation fell as patients got older.

The press release also notes that in many cases, breast conservation therapy consists of breast-conservation surgery plus radiation therapy and that radiation therapy requires frequent treatments over the course of months and can lead to various adverse effects. The SIRA device may present an alternative that helps alleviate the fear of future recurrence.

Reference

1. Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment. News release. Innoblative. April 10, 2025. Accessed April 11, 2025. https://tinyurl.com/2uzxnxpd
2. Innoblative receives U.S. FDA breakthrough device designation for its SIRA RFA electrosurgical device. News release. Innoblative. April 27, 2023. Accessed April 11, 2025. https://tinyurl.com/5n8rm94c
3. Innoblative treats first patient with SIRA device. News release. Medical Device Network. July 17, 2024. Accessed April 11, 2025. https://tinyurl.com/yek56n83
4. Klimberg VS, Ochoa D, Henry-Tillman R, et al. Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. J Am Coll Surg. 2014;218(4):741-749. doi:10.1016/j.jamcollsurg.2013.12.032
5. Kim Y, Ganduglia-Cazaban C, Tamirisa N, Lucci A, Krause TM. Contemporary analysis of reexcision and conversion to mastectomy rates and associated healthcare costs for women undergoing breast-conserving surgery [published correction appears in Ann Surg Oncol. 2024 Jun;31(6):3956. doi: 10.1245/s10434-024-15212-0.]. Ann Surg Oncol. 2024;31(6):3649-3660. doi:10.1245/s10434-024-14902-z