Innoblative Designs announced today that it received FDA investigational device exemption (IDE) for its Sira RFA electrosurgical device. Chicago-based Innoblative Designs’ SIRA device holds FDA breakthrough device designation. It designed SIRA for use in breast cancer patients undergoing breast-conservation surgery (BCS/lumpectomy). SIRA uses radiofrequency ablation (RFA) through a unique spherical shape that circumferentially delivers RF energy. It delivers this energy to the entire cavity and yields reproducible action depths.
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The single-use, disposable applicator delivers greater confidence in treating the margins where residual cancer may reside. Innoblative says RF ablation can reduce reoperations and may reduce local recurrence in breast cancer treatments. However, current conventional RF devices often fail to treat lumpectomy cavities. Using those devices can lead to variable treatment depths and incomplete ablations.
With the FDA IDE, Innoblative Designs can now initiate a U.S. feasibility study of Sira. It plans to evaluate the system’s safety and the effectiveness of SIRA in patients undergoing BCS.
“The SIRA device, specifically designed as an adjunct to BCS, addresses residual cancer in surrounding tissue at the time of the initial lumpectomy procedure,” said Richard Stark, CEO of Innoblative. “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 U.S. feasibility study to further validate our technology, which we believe will be a game-changer for breast cancer patients.”
