Innoblative Designs wins FDA breakthrough nod for ablation device

The SIRA RFA electrosurgical ablation device. [Image courtesy of Innoblative Designs]Innoblative Designs announced today that it received FDA breakthrough device designation for its SIRA RFA electrosurgical device.

Chicago-based Innoblative Designs designed SIRA for use in breast cancer patients undergoing BCS (lumpectomy). The company plans to present data supporting its breakthrough nod this week. It’s presenting at the Annual Meeting for The American Society of Breast Surgeons in Boston.

“The SIRA technology is an exciting advancement in the treatment of breast cancer as it is designed to allow surgeons to address potential residual cancer in the lumpectomy cavity at the time of the initial procedure,” said Dr. Thomas Frazier, medical director, Comprehensive Breast Center at Bryn Mawr Hospital in Pennsylvania. “Designed to augment the lumpectomy procedure, the SIRA device aims to reduce the need for reoperations.”

SIRA uses …

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