Sirius Medical's Pintuition Navigation System Outshines Traditional Methods in Breast Surgery

Pintuition Surgical Marker Navigation: Revolutionizing Breast Localization

Sirius Medical has made a significant leap forward in surgical navigation with the introduction of the Pintuition system, which has recently been validated through the iBRA-NET localization study. This major research effort confirms that Surgical Marker Navigation using Pintuition serves as a superior substitute for traditional wire-guided localization techniques, particularly for identifying impalpable breast lesions.

Study Overview

In what is regarded as the largest international multi-center patient cohort to date, encompassing 1,899 participants, the iBRA-NET study presents compelling evidence for the effectiveness of Pintuition. The results reveal an impressive 99.4% localization success rate, placing it on par with outcomes observed in a substantial cohort utilizing wire-guided localization methods, which involved 1,170 patients. Importantly, Pintuition featured a markedly lower positive margin rate, coming in at 10.4%, compared to 15.0% recorded in the wire-guided cohort (p=0.013). Notably, both re-excision rates and overall safety metrics showed no significant differences between the two treatment methods.

“The data strongly affirms the clinical value of the Pintuition Surgical Marker Navigation,” states Kitty Kempen, the Director of Clinical Medical Affairs at Sirius Medical. “This reinforces our commitment to delivering intuitive navigation solutions that not only enhance surgical accuracy but also streamline procedural workflows and improve the overall patient experience.”

Features of the Pintuition System

The Pintuition system functions similarly to GPS navigation, offering surgeons a precise platform for tumor localization during breast-conserving procedures. One of its distinctive features is TargetLOC®, which notifies surgeons when their probe is directly positioned above the Pintuition marker, accompanied by real-time audio and visual cues. This innovative approach significantly enhances localization precision and alleviates the challenges associated with traditional wire-based techniques.

“This marks the most extensive dataset to date comparing wired localization to a wireless alternative,” remarked Mr. Edward St John, Principal Investigator of the iBRA-NET study. “The findings unequivocally demonstrate that Surgical Marker Navigation with Pintuition stands as a highly effective technique, benefitting both patients and surgical teams.”

Presentation and Future Publications

The pivotal findings of the iBRA-NET study were presented by key researchers, Mr. Edward St John and Mr. Rajiv Dave, during the 2025 Association of Breast Surgery (ABS) Conference. This event further signifies the clinical importance and growing acceptance of Surgical Marker Navigation techniques in breast-conserving surgery. A more comprehensive publication detailing the study's findings is anticipated to be released in the upcoming months.

About iBRA-NET and Sirius Medical

The iBRA-NET represents a coalition of breast and plastic surgeons, allied healthcare professionals, and patients throughout the UK. It stands behind the principle that “no innovation without evaluation,” striving to rigorously assess new surgical techniques, tools, and implants in the field of oncoplastic breast surgery. Supported by prestigious professional organizations like the Association of Breast Surgery (ABS), the Royal College of Surgeons of England (RCSE), and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), they are at the forefront of advancing breast surgery practices.

Sirius Medical has its origins in the Netherlands Cancer Institute and is steadfast in its mission to enhance the care provided to cancer patients. The company focuses on delivering effective yet affordable solutions that facilitate precise tumor removal. The Pintuition technology is designed to be user-friendly, accurate, cost-effective, CE-marked, and FDA-cleared, carving a path for widespread adoption. With an expanding reach of over 50,000 procedures performed globally across more than 250 medical centers, Sirius Medical is committed to innovation in surgical navigation.

Conclusion

The validation of the Pintuition system as a safe and effective surgical navigation tool offers an exciting advancement in the fight against breast cancer. As surgical techniques continue to evolve, the insights and data provided from studies such as iBRA-NET will be invaluable in shaping the future of breast surgery, benefitting both surgeons and patients alike.