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Home » Innoblative Designs wins FDA breakthrough nod for ablation device

Innoblative Designs wins FDA breakthrough nod for ablation device

April 27, 2023 By Sean Whooley

Innoblative Designs SIRA RFA electrosurgical 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 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. Innoblative Designs said this provides greater confidence in a consistent thermal effect.

The company noted that RFA can also reduce operations and local recurrence in breast cancer treatment.

“Receiving a breakthrough designation is a significant achievement and I congratulate the team for their efforts to reach this important milestone,” said Richard Stark, CEO of Innoblative. “We believe the SIRA will be a game changer in BCS for breast cancer and we look forward to bringing this important technology to cancer patients.”

Filed Under: Food & Drug Administration (FDA), Oncology, Regulatory/Compliance, Surgical, Women's Health Tagged With: Innoblative Designs

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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