Innoblative Designs has received FDA Investigational Device Exemption (IDE) approval for its SIRA RFA electrosurgical device, clearing the way for a U.S. feasibility study.
A New Approach to Lumpectomy Margin Treatment
- The SIRA device, a single-use radiofrequency ablation (RFA) applicator, is designed for breast-conserving surgery (BCS).
- Its spherical design delivers circumferential RF energy to the lumpectomy cavity, targeting areas where residual cancer may remain.
- Key benefit: Potential to reduce reoperations and eliminate the need for follow-up radiation therapy.
The device previously earned Breakthrough Device Designation and now advances to clinical evaluation in patients undergoing lumpectomy.
“Initiating the feasibility study marks a major step toward improving outcomes for breast cancer patients,” said CEO Richard Stark.
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