US-based medical device company Innoblative Designs has received clearance from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application.
The approval enables the company to start a feasibility study in the US. The study aims to evaluate the safety and effectiveness of Innoblative’s SIRA RFA Electrosurgical Device in patients undergoing breast-conservation surgery (BCS).
Innoblative CEO Richard Stark said: “The SIRA device, specifically designed as an adjunct to BCS, 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.
“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. We look forward to initiating the US feasibility study to further validate our technology, which we believe will be a game-changer for breast cancer patients.”
The SIRA device is a disposable, single-use applicator designed for use during breast-conserving surgery to perform intraoperative ablation of the cavity left after a lumpectomy.
Its spherical design delivers radiofrequency (RF) energy around the cavity, aiming to achieve uniform ablation depths. This design is intended to ensure that the margins, which might contain residual cancer cells, are adequately treated.
RF ablation has been shown in several long-term studies to potentially reduce the need for additional surgeries and may decrease local recurrence in breast cancer treatment.
At present, there are no RF devices specifically developed for breast cancer treatment. Traditional RF systems are not optimised for treating lumpectomy cavities, often resulting in inconsistent treatment depths and ablations.
The SIRA device aims to address these challenges by reducing positive margin rates and the need for repeat surgeries. Additionally, it offers a non-ionizing therapeutic alternative to radiation therapy for certain patients, which may help reduce healthcare expenses and enhance patient care.
Innoblative aims to provide an alternative treatment option that addresses these issues and reduces concerns about cancer recurrence. The SIRA Device is currently investigational for use in BCS in the US.
