Innoblative

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Check out Innoblative’s webinar from December 13th 2022

Innoblative’s SIRA™ RFA Electrosurgical Device

Innoblative’s latest data of ablation in human breasts was accepted for presentation at the annual meeting of the American Society of Breast Cancer Surgeons (ASBrS). The abstract, titled Multi-investigator Pilot Study of Post-Lumpectomy Radio-frequency Ablation (“RFA”) for Margin Extension and Local Control in Mastectomy Model, has been accepted as a poster presentation at the Society’s 24thAnnual Meeting on April 26 – 30, 2023 in Boston, MA. The abstract will be published in the Annals of Surgical Oncology as part of the ASBrS Official Proceedings in the spring. 

The abstract will present data from multiple different investigators who used the now FDA-cleared Innoblative SIRA™ RFA Electrosurgical Device to successfully ablate (“treat”) a zone of breast tissue around a lumpectomy cavity. The SIRA device is a first-in-class Saline-coupled Intra-cavitary RfA device specifically designed to fit the post-lumpectomy breast cavity and deliver uniform post-lumpectomy cavity ablation for margin extension and local control.

The previous single investigator data was published as abstract titled A Novel Technology for Uniform Post-Lumpectomy Radio-frequency Ablation for Margin Extension and Local Control Tested in IRB-approved Pilot Mastectomy Study and presented at the 2020 annual San Antonio Breast Cancer Symposium.

The study tested the SIRA device’s ablation performance in human breasts of patients undergoing prophylactic mastectomy. The device settings and ablation dose (i.e., power and duration) were previously optimized within this same model to target a ~1cm ablation depth, where residual cancer cells are most likely to be located. The study was designed to evaluate the repeatability and uniformity of the optimized settings across multiple patients.

The results of this study confirmed the feasibility of the Sira™ device to create consistent and effective uniform ablations to targeted depth of ~1cm around a lumpectomy cavity in fresh human breasts undergoing mastectomy. The prophylactic mastectomy model allows for analysis of the SIRA in freshly excised ex vivo tissue to provide nearly identical electrical conductivity, thermal conductive, and mechanical stress-strain properties as in vivo breast tissue. Ultimately, these data show proof-of-concept for the SIRA device to provide margin extension and local control, which may ultimately reduce the need for reoperations and for adjunctive radiation in select breast cancer patients.

For more information please contact Matthew T. Sheridan at Matthew@SpotlightFamilyOffice.com.