DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Dilon Medical Technologies, Ltd.The MarginProbe System by Dune Medical Devices is a medical device that helps surgeons detect cancerous tissue at the margins of breast lumpectomy specimens during surgery. It uses radio frequency spectroscopy and a specialized sensor to analyze the tissue's dielectric properties, giving real-time feedback on whether the tissue margins contain cancer cells. This enables surgeons to remove additional tissue if needed while potentially reducing repeat surgeries. The device is particularly used during breast conserving surgeries to improve cancer removal outcomes.
Intended Use
An adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision during breast lumpectomy surgery.
Technology
The device uses RF spectroscopy generating an oscillating transient electrical field at the probe tip. The probe applies an electric field to breast tissue and measures reflected signals across a range of 50MHz–500MHz frequencies. A classification algorithm analyzes resonance frequency and signal amplitude to determine malignancy based on pre-established criteria. The probe is a sterile, single-use component connected to a console with display and audio. The effective tissue measurement area is 7mm diameter, focused on ≤1mm depth of the margin. The device outputs positive or negative margin status for breast lumpectomy specimens.
Performance
The device was evaluated in a pivotal, multicenter, randomized clinical trial with 596 patients comparing standard of care (SOC) lumpectomy to SOC with adjunctive MarginProbe use. The primary effectiveness endpoint was a 5 percentage point reduction in reoperation rate in the MarginProbe arm. Sensitivity and specificity per margin were 75% and 46% respectively. No major device-related safety concerns were noted. Additional bench, software, biocompatibility, sterilization, and equivalence tests demonstrated compliance and no performance degradation with commercial device updates.
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