Pintuition Validated as a Safe and Reliable Navigation Solution by Large Real-World Data from the iBRA-NET study
EINDHOVEN, Netherlands, May 20, 2025 /PRNewswire/ -- Sirius Medical proudly announces positive results from the iBRA-NET localization study, confirming that Surgical Marker Navigation using the Sirius Pintuition® system is a highly effective and safe alternative to traditional wire-guided localization for impalpable breast lesions.
In the largest international multi-center patient cohort to date (n=1899), the study demonstrated that Pintuition achieved an excellent 99.4% localization success rate, comparable to that of a large wire-guided localization cohort (n=1170). Notably, Pintuition was associated with a significantly lower rate of positive margins (10.4% vs. 15.0%, p=0.013), while re-excision rates and overall safety outcomes did not differ significantly between the two groups.
"These results further validate the clinical value of Pintuition Surgical Marker Navigation," said Kitty Kempen, Director of Clinical & Medical Affairs at Sirius Medical. "They reinforce our mission to provide intuitive navigation solutions that enhance surgical precision, streamline workflows, and elevate the patient experience."
The Pintuition system offers surgeons a GPS-like navigation platform for precise tumor localization during breast-conserving surgery. It features TargetLOC®—a unique function that indicates when the probe is directly aligned above the Pintuition marker—combined with real-time audio and visual guidance. This enables unmatched precision, streamlines tumor localization, and overcomes the limitations of traditional wire-based methods.
"This is the largest prospective dataset to date comparing wire localization with a wireless alternative," said Mr. Edward St John, Principal Investigator of the iBRA-NET study. "The results demonstrate that Surgical Marker Navigation with Pintuition is non-inferior to wire-based localization. Pintuition is a highly effective technique with tangible benefits for patients and surgical teams alike."
The iBRA-NET Pintuition results were presented by Mr. Edward St John and Mr. Rajiv Dave during the 2025 Association of Breast Surgery (ABS) Conference, further underscoring the clinical relevance and momentum behind Surgical Marker Navigation in breast-conserving surgery. A full publication is expected in the coming months.
About iBRA-NET
The iBRA-NET is a multidisciplinary network of breast and plastic surgeons, allied healthcare professionals, and patients from across the UK. Guided by the mission "no innovation without evaluation," we are committed to the rigorous assessment of new surgical techniques, devices, and implants within the field of oncoplastic breast surgery.
Our work is supported by leading professional bodies, including 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).
About Sirius Medical
With its roots deeply embedded in the Netherlands Cancer Institute, Sirius Medical is dedicated to improving care for cancer patients by delivering unsurpassed yet affordable solutions that enable precise and efficient removal of tumors. The Pintuition® technology is simple, precise, affordable, CE-marked, and FDA-cleared. Sirius Medical is rapidly expanding with over 50,000 procedures worldwide in more than 250+ centers and a global commercial network covering the USA, Western Europe, Australia, and New Zealand.
Media Contact:
Benjamin Tchang
Global Marketing Director
Sirius Medical
+31 647 852 805
[email protected]
Photo - https://mma.prnewswire.com/media/2691064/Pintuition.jpg
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