FDA grants breakthrough device status to Innoblative’s SIRA

FDA grants breakthrough device status to Innoblative’s SIRA

Time Stamp: April 28, 2023 11:02 AM
Source Node: 2614959

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The SIRA RFA Electrosurgical Device is specifically designed for use in breast cancer patients, who are undergoing breast-conserving surgery. Credit: Innoblative Designs/PRNewswire.

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Innoblative Designs’ SIRA RFA Electrosurgical Device.

SIRA has been specifically designed for use in breast cancer patients who are undergoing breast-conserving surgery (BCS), which is commonly referred to as lumpectomy.  

It has a unique spherical shape that allows circumferential delivery of radiofrequency (RF) energy.

The device delivers RF energy to the entire cavity and enables reproducible action depths. This provides greater confidence in a consistent thermal effect, the company said.

In several long-term clinical trials, RF ablation was found to reduce reoperations as well as local recurrence in breast cancer treatment.

Innoblative CEO Richard Stark said: “Receiving a breakthrough designation is a significant achievement and I congratulate the team for their efforts to reach this important milestone.

“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.”

The SIRA device features a 4cm diameter spherical electrode which creates a wide ablation zone that covers a large surface area per ablation.

It is claimed to safely facilitate the accurate removal of clinical targets.

It has a larger applicator that helps avoid painting a tissue surface and physician-controlled settings will allow to customise ideal ablation performance.

Dr Thomas Frazier, medical director at Bryn Mawr Hospital Pennsylvania Comprehensive Breast Center, said: “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.

“Designed to augment the lumpectomy procedure, the SIRA device aims to reduce the need for reoperations.”

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