Innoblative Designs announced today that the U.S. Food and Drug Administration has approved its Investigational Device Exemption (IDE) application for the SIRA® RFA Electrosurgical Device, paving the way for a U.S. feasibility study in patients undergoing breast-conserving surgery (BCS).
The SIRA device, which previously received FDA Breakthrough Device designation in April 2023, is designed to address residual cancer in surrounding tissue during the initial lumpectomy procedure, potentially eliminating the need for subsequent radiation therapy or reoperations.
"We are thrilled to have secured IDE approval, a significant milestone for the company and a testament to the team's hard work and dedication," said Richard Stark, CEO of Innoblative. "We look forward to initiating the U.S. feasibility study to further validate our technology, which we believe will be a game-changer for breast cancer patients."
How the SIRA Technology Works
The SIRA device is a single-use, disposable applicator built specifically for intraoperative ablation of the post-lumpectomy cavity during breast-conserving surgery. Its unique spherical design allows for circumferential delivery of radiofrequency (RF) energy, yielding reproducible ablation depths to the entire cavity.
This approach provides surgeons with greater confidence that the margins, where residual cancer may reside, have been adequately treated. RF ablation has demonstrated promising results in multiple long-term clinical studies, showing potential to reduce reoperations and local recurrence in breast cancer treatment.
Currently, there are no RF devices specifically designed for breast cancer treatment. Conventional RF systems are not optimized for treating lumpectomy cavities, often resulting in inconsistent treatment depths and ablations.
Addressing a Significant Clinical Need
Breast cancer remains the most commonly diagnosed cancer globally, affecting millions of women each year. Once diagnosed, patients face difficult decisions regarding available treatment options.
Breast conservation therapy (BCT), which typically includes breast-conserving surgery plus radiation therapy, is a common approach. However, BCS is associated with a high rate of reoperation, with approximately one in five patients requiring a follow-up procedure within weeks of the initial excision to address residual cancer.
A retrospective cohort study revealed that for patients with commercial insurance, the reoperation rate was 21.1%, with mean healthcare costs at one year of follow-up reaching $95,165. For Medicare patients, the reoperation rate was 14.9%, with costs averaging $36,313.
Additionally, subsequent radiation therapy can be challenging for patients, requiring frequent treatments over several weeks or months and potentially causing a range of unpleasant side effects.
Clinical Experience and Future Directions
In July 2024, Innoblative announced that a 64-year-old patient in Istanbul, Turkey, with stage II breast cancer, became the first to be treated with the SIRA device.
The treating surgeon, Cem Yilmaz, MD, reported: "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."
Previous research supports the potential of this approach. 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.
Potential Impact on Patient Care
The SIRA device aims to provide multiple benefits for breast cancer patients and the healthcare system:
- Reduction in positive margin rates
- Fewer BCS reoperations
- A one-time non-ionizing therapeutic alternative to radiation therapy for select patients
- Potential reduction in healthcare costs
- Improved patient experience and quality of life
The upcoming U.S. feasibility study will evaluate both the safety and effectiveness of the SIRA RFA Electrosurgical Device, with results eagerly anticipated by clinicians and patients alike.
It's important to note that the SIRA device remains investigational for use in BCS in the United States, with the IDE approval representing a crucial step toward potential broader clinical application.
