The US Food and Drug Administration (FDA) has granted approval for Innoblative Designs' investigational device exemption (IDE) application, allowing the medical device company to begin a feasibility study in the US to assess its SIRA RFA electrosurgical device in subjects undergoing breast-conservation surgery (BCS).

This single-use device is a disposable applicator designed for the intraoperative ablation of the post-lumpectomy cavity during BCS.

Innoblative Designs claims that SIRA's spherical design enables the circumferential delivery of radiofrequency (RF) energy and yields reproducible ablation depths to the cavity.

This feature is critical for treating the margins where remaining cancer cells may be present.

The company stated that RF ablation has been indicated in several long-term clinical studies to reduce reoperations and local recurrence in breast cancer treatment.

The device aims to decrease positive margin rates, reduce the requirement for BCS reoperations, and provide a one-time non-ionising therapeutic option to radiation therapy in certain individuals.

Innoblative Designs CEO Richard Stark said: “The SIRA device, specifically designed as an adjunct to BCS, addresses residual cancer in surrounding tissue at the time of the initial lumpectomy procedure. The technology provides a more palatable option for patients and aims to eliminate the need for subsequent radiation therapy or reoperations.

“We look forward to initiating the US feasibility study to further validate our technology, which we believe will be a game-changer for breast cancer patients.”

Individuals diagnosed with breast cancer face challenging decisions about their treatment options.

Breast conservation therapy (BCT), which includes BCS and radiation therapy, is a common recommendation. However, BCS is claimed to have a high re-operation rate.

Nearly one in five subjects may need a follow-up process shortly after the initial procedure to remove residual cancer.

Furthermore, the following radiation therapy can be burdensome, involving frequent treatments over an extended period and potential side effects. 

The company aims to offer an alternative treatment option to address these issues.

The device is currently investigational for BCS use in the US, the company stated.

Innoblative announced the first-in-human use of the SIRA device for breast cancer treatment last year.