Frequently asked questions

FAQ

Siruis Pintuition performance

What is the chance of Pintuition Marker 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 Pintuition Marker compatible with MRI imaging?

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

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

Yes, in the EU the Pintuition Marker is approved for use in any soft tissue lesion up to 180 days prior to removal. For the US the current indication is soft tissue and long term.

Please refer to your local Instructions for Use document for the complete indications for use.

How long in advance can the marker be placed?

In the EU the Pintuition Marker may be placed up to 180 days in advance of surgery. In the US the marker has the long term indication.

Is the Pintuition Marker visible on my imaging system?

The Pintuition Marker 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 Marker 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