Innoblative’s SIRA Device: A Potential Game-Changer for Lumpectomy Patients

Innoblative's SIRA Device: A Potential Game-Changer for Lumpectomy Patients

by John Conrad| Jul 17, 2024| NewsBrief

A groundbreaking medical device designed to improve breast cancer treatment has successfully completed its first human trial. Innoblative Designs, Inc., a Chicago-based medical device company, announced on July 16, 2024, that its SIRA® RFA Electrosurgical Device was used to treat a 64-year-old patient with stage II luminal A breast cancer.

The procedure, performed by Dr. Cem Yilmaz at the Istanbul Oncology Hospital in Turkey, marks a significant milestone in breast cancer treatment. The SIRA device is specifically designed for patients undergoing breast-conserving surgery (BCS), commonly known as a lumpectomy.

Breast cancer remains a global health concern, with over 2.3 million new cases diagnosed each year. Currently, patients who opt for breast conservation therapy often face challenges such as high reoperation rates and the need for extensive radiation therapy following surgery.

The SIRA device aims to address these issues by allowing surgeons to ablate potential residual cancer cells in the cavity immediately after tumor removal. Dr. Yilmaz expressed enthusiasm about the procedure, stating, "It was extremely easy to use, and I was able to completely ablate the cavity post-lumpectomy without complications." He believes this technology could make breast conservation surgery a more attractive option for patients by potentially eliminating the need for subsequent radiation therapy or reoperations.

Innoblative's device utilizes radiofrequency (RF) energy to target soft tissue around the surgical site. Its unique spherical shape allows for consistent and thorough treatment of the entire cavity, potentially improving upon conventional RF devices that may lead to variable treatment depths and incomplete ablations.

While the SIRA device has received FDA Breakthrough Designation for use in breast-conserving surgery, it is not yet available for sale in the United States for this purpose. However, this successful first-in-human use represents a significant step forward in its development and potential future availability to patients.

Richard Stark, CEO of Innoblative, expressed excitement about the company's transition to a commercial entity and the potential impact of their technology on breast cancer treatment.

As clinical trials progress, the medical community and breast cancer patients alike will be watching closely to see if this innovative approach can indeed revolutionize breast conservation therapy, offering a less invasive and potentially more effective treatment option for millions of women worldwide.

Read the press release

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