#Netherlands #Eindhoven #Sirius Medical #Pintuition #iBRA-NET

Pintuition Validated as an Alternative Navigation Tool for Breast Surgery

In a groundbreaking revelation for breast cancer surgery, Sirius Medical has announced positive findings from the iBRA-NET localization study that validates the Pintuition system as a safe and effective navigation solution. This validation stems from one of the largest international multicenter patient cohorts, comprising 1,899 patients, showcasing an impressive localization success rate of 99.4%. This figure rivals the traditional wire-guided localization method, which included 1,170 patients.

Pintuition leverages real-world data to demonstrate its efficiency, particularly when compared to wire localization. Significantly, the study recorded a lower rate of positive margins with Pintuition at 10.4%, compared to 15.0% in the wire-guided group (p=0.013). Despite these promising outcomes, rates of re-excision and overall safety did not differ substantially between the two methods, underscoring Pintuition's reliability.

Dr. Kitty Kempen, Clinical and Medical Affairs Director at Sirius Medical, emphasized the importance of these findings, remarking, "These results further validate the clinical value of Pintuition Surgical Marker Navigation. They reinforce our mission to provide intuitive navigation solutions that enhance surgical precision, streamline workflows, and improve patient experiences."

The Pintuition system operates much like a GPS, allowing surgeons to accurately locate tumors during breast-conserving surgery. One of its standout features, TargetLOC®, indicates when the probe is directly aligned over the Pintuition marker, providing real-time visual and auditory guidance. This innovative approach significantly improves accuracy, expedites tumor localization, and addresses the limitations associated with traditional wire methods.

Dr. Edward St. John, the lead investigator of the iBRA-NET study, stated, "This is the largest prospective dataset to date comparing wire localization with a wireless alternative. The results show that surgical marker navigation with Pintuition is non-inferior to wire localization. Pintuition presents a highly effective technique that offers tangible benefits for both patients and surgical teams."

The iBRA-NET Pintuition results were presented by Dr. St. John and Rajiv Dave at the 2025 Association of Breast Surgery (ABS) Conference, highlighting the clinical relevance and momentum behind Surgical Marker Navigation in breast-conserving surgery. A more comprehensive publication is anticipated in the coming months.

About iBRA-NET

iBRA-NET is a multidisciplinary network of breast and plastic surgeons, allied healthcare professionals, and patients across the United Kingdom. Guided by the principle that "no innovation comes without evaluation," iBRA-NET is committed to rigorously assessing new surgical techniques, devices, and implants in the oncoplastic breast surgery domain. Supported by key professional bodies such as 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), iBRA-NET stands at the forefront of improving surgical practices.

About Sirius Medical

With deep roots in the Netherlands Cancer Institute, Sirius Medical strives to enhance cancer patient care through unparalleled and affordable solutions that facilitate precise and efficient tumor removal. Their Pintuition technology, which is user-friendly, accurate, and CE-marked along with FDA authorization, is rapidly expanding with over 50,000 procedures performed across more than 250 centers globally and a commercial network spanning the U.S., Western Europe, Australia, and New Zealand.