The clinical perspective

Why pinpoint localization?

Localization techniques are here to stay

Population-wide screening programs for breast cancer have led to a sharp increase in the detection rate of small and non-palpable breast tumors. As a consequence, surgeons are faced with increasingly challenging procedures as they must locate and operate these demanding tumors. Surgical localization techniques are indispensable in guiding the surgeon to the right location during breast cancer surgery.

 

The gold standard is on its last legs

Wire-guided localization (WL) has been the gold standard for these procedures ever since its introduction in the 1970s [1]. However, the use of wires is not ideal.

Clinics need to carefully plan their radiology and surgery schedules to prevent delays; surgeons do not have freedom of approach, as the wire entry site may be different from the ideal skin incision location and the wire placement procedure leads to additional pain and stress on an already stressful surgery day for patients.

 

Surgeons demand change

Now, more than 40 years after the introduction of wire-guided localization, it’s time for a change. In recent years, new devices have been developed that overcome many of the disadvantages of wires. Of these, radioactive seed localization (RSL) is the most prominent newcomer. However, the use of tiny radioactive sources and its strict chain of custody requirements introduce radiation safety concerns, resulting in limited adoption.

 

From bench to bedside: a short history of Sirius Pintuition

Born and raised in the Netherlands Cancer Institute, the Sirius Pintuition System has its roots firmly embedded in the surgical clinic. A part of the team was the first to develop a magnetically detectable seed (MaMaLoc) compatible with a commercially available susceptibility-based magnetic detector. Subsequently, we showed feasibility of magnetic localization for non-palpable breast cancer [2]. After the introduction of comparable devices, we showed that the unique configuration of the MaMaLoc marker was best equipped for magnetic localization [3].

Nevertheless, conventional solutions towards magnetic localization were not up to our surgeons’ requirements. Limited detection range, non-directional detection and strong interference from conventional surgical instruments were a strong driver for us to develop our own system. Sirius Pintuition uses magnetism in an entirely novel way which solves the issues of conventional magnetic detection systems.

 

Sirius Pintuition: the next generation

Sirius Pintuition is a next generation localization system. At Sirius, we foresee a future where surgical treatment of early-stage cancer relies on our proprietary non-radioactive, point-source localization technique. Sirius Pintuition provides directional and intuitive localization with millimeter accurate real time distance feedback. The Pintuition Probe is reusable, robust and very simple to use. Sirius Pintuition will provide access to the benefits of radioactive seeds without any of its safety concerns.

Building clinical evidence

Safety and performance: clinical investigation

Sirius Medical has an ongoing clinical investigation that focuses on safety and performance. We are happy to share our first clinical results with you soon. If you would like to receive an update about our clinical trial results, please leave your email address at our contact page.

 

SiriusLink: improving care while saving money

At Sirius, we are committed to keeping the healthcare system in balance. We want to deliver on our key promise: when switching from wires to Sirius Pintuition, your costs when measured across the surgical patient care pathway should not increase.

Seed based localization technologies such as Sirius Pintuition decouple radiology and surgery schedules which provides planning benefits and reduces delays, and in turn, reduces costs.

For example, Sharek et al. found that after transitioning from wires to radioactive seeds they had a productivity increase of 34% and a decrease in average wait time of 45% [4]. In a Monte Carlo simulation of cost-benefit when switching from wires to radioactive seeds, Loving et al. concluded that for a bundled payment system the total health care cost per patient was reduced by $115, and for fee-for-service system with $595 [5]. Moreover, both studies factored in significant costs specifically for using radioactive seeds (such as certified Nuclear Medicine personnel) which costs can be additionally saved when using Sirius Pintuition

Sirius Medical recognizes that care pathways are unique for each clinic. Our SiriusLink program was designed to identify the true time and cost benefit to be gained when switching to Sirius Pintuition, regardless of the type of clinic. With the data obtained from the SiriusLink program, Sirius wants to help clinics build a business case that is specific for their clinic.

Our promise to the clinic

We strive to be a trusted partner in the clinic and the surgical treatment of cancer patients:

  • Intuitive and accurate devices that enable surgeons to deliver optimal care
  • Compelling evidence on performance, outcomes, and health-economics
  • Affordable solutions that provide value across the patient care pathway

References

[1] H. A. Frank, F. M. Hall, and M. L. Steer, “Preoperative Localization of Nonpalpable Breast Lesions Demonstrated by Mammography,” N. Engl. J. Med., vol. 295, no. 5, pp. 259–260, Jul. 1976.

[2] B. Schermers et al., “Feasibility of magnetic marker localisation for non-palpable breast cancer,” Breast, vol. 33, pp. 50–56, 2017.

[3] B. Schermers,  ten H. Bennie, S. Muller, J. A. van der Hage, and T. J. M. Ruers, “Optimization of an implantable magnetic marker for surgical localization of breast cancer,” Biomed. Phys. Eng. Express, vol. 4, no. 6, 2018.

[4] D. Sharek, M. L. Zuley, J. Y. Zhang, A. Soran, G. M. Ahrendt, and M. A. Ganott, “Radioactive seed localization versus wire localization for lumpectomies: A comparison of outcomes,” Am.

[5] V. A. Loving et al., “Monte Carlo simulation to analyze the cost-benefit of radioactive seed localization versus wire localization for breast-conserving surgery in fee-for-service health care systems compared with accountable care organizations,” Am. J. Roentgenol., vol. 202, no. 6, pp. 1383–1388, Jun. 2014.