Frequently asked questions

We're always happy to discuss the features and advantages of the Sirius Pintuition system with you. You can find answers to the most frequently asked questions here.

System general

What is the Sirius Pintuition system?

Sirius Pintuition is a surgical localization technology for the treatment of non-palpable breast cancer and other soft tissue tumor types.

What are the main advantages of Sirius Pintuition?

Sirius Pintuition is a radioactive-free, wire-free surgical localization system. Our system has intuitive and directional, millimetre-accurate detection with a range of 50mm. Our probe is fully reusable and compatible with conventional surgical tools. Sirius Pintuition is an affordable solution that can improve the productivity of tissue sparing surgeries.

Where can I get instructions for using the Sirius Pintuition system?

The Instructions for use will be available from our support page.

Where can I find detailed information about the Sirius Pintuition system?

Technical specifications are part of the instructions for use, which will be available from our support page. If you would like to receive more information or have any questions, please let us know and we’ll be in touch.

Where can I try out the Sirius Pintuition system?

Sirius provides personal live online demonstrations of the Sirius Pintuition system, you can book a timeslot here. Also we are present on all the major international conferences in the surgical oncology field and will announce new events in our newsletter on social media and on this webpage. Please subscribe to our newsletter or follow us on social media (twitter/linkedin) to stay in touch.

I’m interested, how can I get more information?

We’re happy to hear you are interested in Sirius Pintuition. Please leave your contact details here and we’ll be in touch or go ahead and book an live online demonstration

Product performance

What is the chance of Pintuition Seed migration?

Smaller, radioactive iodine seeds have been shown not to migrate [1] and a previous version of the Sirius Pintuition device was associated with negligible migration (all <1mm) after an implantation duration of median 18 (13-29) days, N=5 [2]”.

[1] Alderliesten T, Loo CE, Pengel KE, Rutgers EJT, Gilhuijs KGA, Vrancken Peeters MTFDJTFD. Radioactive seed localization of breast lesions: an adequate localization method without seed migration. Breast J [Internet]. United States; 2011; 17: 594– 601. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21906208

[2] Schermers B, van der Hage JA, Loo CE, Vrancken Peeters MTFD, Winter-Warnars HAO, van Duijnhoven F, et al. Feasibility of magnetic marker localisation for nonpalpable breast cancer. Breast [Internet]. Elsevier Ltd; 2017; 33: 50–56. Available from: http://dx.doi.org/10.1016/j.breast.2017.03.003

Is the Sirius Pintuition seed compatible with MRI imaging?

The Pintuition Seed is labelled as MR conditionally safe; this means patients with a Pintuition Seed in situ can safely undergo an MR scan (under certain conditions), but this will lead to image artefacts around the Seed. The Pintuition Needle is not safe for use during MRI, so it is not safe to implant the seed under MR guidance. Please refer to the Instructions for Use for specific information.

Is the Pintuition Seed approved for use during neoadjuvant therapy and how does this impact MRI response evaluation?

There is no contra-indication for the use of Pintuition during neoadjuvant therapy. The device is approved for use both in the primary lesion and in lymph nodes. However, the clinicians should be aware of the imaging artefact on MRI. In a worstcase test setting the maximum artefact extended approximately 6cm from the seed. The minimum artefact extends 2,5 cm from the seed. The artefact in your center will depend on your own imaging settings and system. If you are interested we can provide a detailed test report.

Is the Pintuition Seed approved for use in the Axilla or Inguinal lymph nodes?

Yes, in the EU the Pintuition Seed is approved for use in any soft tissue lesion up to 180 days prior to removal. For the US the current indication is breast tissue. Please refer to your local Instructions for Use document for the complete indications for use.

How long in advance can the seed be placed?

In the EU the Pintuition seed may be placed up to 180 days in advance of surgery. In the US this is 30 days prior to surgery.

Is the Sirius Pintuition Seed visible on my imaging system?

The Pintuition Seed is visible on the most common imaging modalities, including ultrasound and x-ray/mammography.

How is the transcutanuous detection experience with larger breasts and the Sirius Pintuition System?

The Pintuition Seed can be detected up to 50mm from the probe. Sirius recognizes the necessity of the functioning of the technique in larger breasts. In our clinical studies with Sirius Pintuition there was no selection on breast size and transcutaneous detection was succesful in all cases [1]. In post-marketing feedback, there have been no complaints on non-functioning transcutaneous detection.

[1]. Bessems M, van Breest Smallenburg V, van Bebber I, et al. Safety and performance of Sirius Pintuition – a novel wire-free and non-radioactive localization system for breast cancer surgery. Eur J Surg Oncol. 2021;47(2):e1. doi:https://doi.org/10.1016/j.ejso.2020.11.148

Ordering

Can I order a Sirius Pintuition System?

Sirius Medical is launching its commercial presence in Europe and will start actively promoting and selling the Sirius Pintuition system in the Netherlands, the United Kingdom and Germany.

Orders and deliveries outside this region will be possible soon. We will continuously update the countries with commercial access.

To find out directly how you can get access to the Sirius Pintuition System in your country. Please leave your email address at our contact page and we will get in touch.

Is the Sirius Pintuition system affordable?

At Sirius Medical, we are committed to keeping the healthcare system in balance by offering an affordable solution. If you are interested what this means for your practice, we would be more than happy to share our value efforts and the possibility of building a business case for your specific situation. Please leave your contact details and we’ll be in touch.

Do you have a question?

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