FDA Clears Sirius Pintuition® for Long-term and Soft Tissue Implantation

Eindhoven, Netherlands November 14, 2023In a ground-breaking development, Sirius Medical, the leader in Surgical Marker Navigation, has received FDA clearance for the expanded use of its Pintuition Marker. This expansion now permits long-term implantation and includes marking soft tissue[1].

Sirius Medical has been steadily raising the bar for the surgery of non-palpable breast tumors by moving from previous localization techniques to Surgical Marker Navigation. The Pintuition System combines both real-time distance and directional navigational guidance to help surgeons locate tumors easily and accurately.

The expanded indications support the placement of the Pintuition marker in soft tissues such as lymph nodes and sarcomas and allows for the placement of the marker at any time during the clinical are pathway. These expanded indications have been in place under the CE mark since Pintuition’s inception and have played an integral role in clinical practice across Europe.

“We have implemented Pintuition at our facility and have embraced surgical marker navigation for its precision and simplicity, states Amy Bremner, MD, Medical Director for Breast Surgical Oncology at Saddleback Medical Center. “These expanded indications for both long term and soft tissue placement will enhance our flexibility. “

Dr. Gary Levine, Medical Director at MemorialCare Breast Center, adds, “The Pintuition System is a robust and reliable tumor navigation system. The expanded indications offer more efficiency and will allow my team to expand its use in our breast care clinical pathways.”

Sirius Medical's CEO, Bram Schermers, shares his enthusiasm: “The expanded FDA clearance signals a promising future for surgical marker navigation. Together with our recently released Pintuition Slim Probe, our robust technology, and these expanded indications, we aim to improve the patient experience and empower physicians with more options.”

For more information about Sirius Medical please visit www.sirius-medical.com

[1] Please refer to the latest IFU for the full Indications for Use statement.

About Sirius Medical

With its roots deeply embedded in the Netherlands Cancer Institute, Sirius Medical is dedicated to improving care for cancer patients by delivery of unsurpassed, yet affordable solutions that enable precise and efficient removal of tumors. The Pintuition technology is precise, simple, affordable and both CE marked, and FDA cleared. Sirius Medical is rapidly expanding with over 14.000 procedures worldwide in over ­­­­200+ centers combined with a global commercial network covering US, Western Europe, and Australia-New Zealand.

Media Contact:

Benjamin Tchang - Corporate contact
+31 857 732 727 (The Netherlands)