The FDA has given clearance for the extended and soft tissue implantation of Sirius Pintuition®

Wednesday, November 15, 2023

In a groundbreaking development, Sirius Medical, a pioneering force in Surgical Marker Navigation, has received FDA clearance to broaden the utilization of its Pintuition Marker. This expanded clearance now encompasses long-term implantation and the marking of soft tissue. Sirius Medical has been revolutionizing the approach to non-palpable breast tumor surgery, transitioning from conventional localization methods to Surgical Marker Navigation.

The Pintuition System seamlessly integrates real-time distance and directional navigational guidance, facilitating surgeons in precisely locating tumors with efficiency. The extended indications now permit the placement of the Pintuition marker in soft tissues, including lymph nodes and sarcomas, enabling marker insertion at any stage in the clinical pathway. These extended indications, present since the initiation of Pintuition under the CE mark, have been instrumental in shaping clinical practices across Europe.

The recent FDA clearance for both long-term and soft tissue placement signifies heightened adaptability. The Pintuition System stands out as a sturdy and dependable tumor navigation system. The expanded indications promise increased efficiency, empowering my team to diversify its application in our breast care clinical pathways. This broadened FDA clearance marks a promising progression for surgical marker navigation, coupled with the introduction of our recently unveiled Pintuition Slim Probe, showcasing our state-of-the-art technology and the potential for broader applications.


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