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Localisation Technologies: Submitted Innovations

The below content has been supplied directly by innovators/industry and does not imply endorsement from iBRA-NET.

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01

LOCalizer is a radio-frequency based localisation device to assist breast surgeons to accurately excise breast lesions. The radio-frequency (r/f) tag is placed in the tumour by the radiologist up to 30 days before surgery (30 days is a temporary, regulatory requirement). All patients electing for breast surgery may have tags placed at one clinic, up to a month before surgery, thus improving Radiology Department workflow. On the day of surgery, the breast list may start as soon as the patient attends without any delay while a patient attends radiology, for a wire to be placed. In Theatre, the surgeon locates and identifies the closest point above the skin to the r/f tag with use of a hand-held reader. Having made the incision, a (disposable) probe is fitted to guide the surgeon directly to the r/f tag to excise the lesion. LOCalizer is extremely sensitive and effective without any cause for concern to the patient present that exists with radioactivity and to a lesser extent magnetism. LOCalizer is now available in the UK having received CE accreditation in January 2019.

02

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Magseed is a small marker which helps to guide surgeons during lumpectomies for impalpable breast cancer. Magseed removes the inaccuracy, inconvenience and complications of wire-guided breast surgery. Magseed gives surgeons, patients and hospitals more flexibility over their scheduling treatment, compared to wire or radioseed localisation, with its ability to be implanted days or weeks before surgery. Magseed is firmly implanted using a small 18-gauge needle with the help of either ultrasound or mammography and its innovative twisted structure is designed to give it high visibility under imaging as well as helps to keep it in place. At the time of surgery, Magseed is detected by the Sentimag probe, which guides the surgeon accurately to the seed ensuring the tumour can be removed in one piece and reduces the likelihood of further surgery. Magseed is detected using the same Sentimag platform as Magtrace, a lymphatic mapping agent for sentinel node biopsy, making it the world’s first and only non-radioactive platform that offers both seed localisation and sentinel node biopsy. Sentimag has been used in over 40,000 procedures around the world, offering surgeons greater accuracy and flexibility in the management of patients. Magseed was first launched in the US in 2016 and is now commercially available in over 30 countries.

 

References:

  • Price, E., Khoury, A., Esserman, L., Joe, B. and Alvarado, M. (2018). Initial Clinical Experience With an Inducible Magnetic Seed System for Preoperative Breast Lesion Localization. American Journal of Roentgenology, 210(4), pp.913-917.

  • Harvey, J., Lim, Y., Murphy, J., Howe, M., Morris, J., Goyal, A. and Maxwell, A. (2018). Safety and feasibility of breast lesion localization using magnetic seeds (Magseed): a multi-centre, open-label cohort study. Breast Cancer Research and Treatment, 169(3), pp.531-536.

  • Hersi, A., Eriksson, S., Ramos, J., Abdsaleh, S., Wärnberg, F. and Karakatsanis, A. (2018). A combined, totally magnetic technique with a magnetic marker for non-palpable tumour localization and superparamagnetic iron oxide nanoparticles for sentinel lymph node detection in breast cancer surgery. European Journal of Surgical Oncology.

03

SCOUT® is an advanced wire-free system designed to improve the precision and predictability of marking tumours, biopsy sites and lymph nodes prior to neoadjuvant therapy and surgery. Instead of wire placement on the day of breast surgery, a reflector smaller than a grain of rice is placed into the targeted tissue at any time prior to surgery. During surgery, the SCOUT radar system with real-time distance measurement and a 60-mm detection range is used to identify the exact location of the reflector within 1-mm of accuracy. The SCOUT system is available at over 760 hospitals and health systems across the US and to date, over 160,000 women have benefitted from enhanced outcomes and an improved overall treatment experience with SCOUT. SCOUT® received CE Mark for distribution of the device in European markets in 2020, laying the groundwork for utilization on a global scale. About SCOUT® The SCOUT Radar Localization System is used for both breast surgical localization, before or after neoadjuvant chemotherapy, and to mark a biopsy site. The SCOUT Reflector has a clinically insignificant MRI artefact, it does not interfere with MRI studies, so there is no restriction on the imaging modalities that can be used effectively throughout treatment. With over 45 published clinical articles and abstracts, the SCOUT system has been proven to be easy to use and provides accurate detection and precise localization. SCOUT also has been shown to improve radiology workflow and significantly reduce OR delays.

 

References:

  • Kasem I, Mokbel K. 'SAVI SCOUT Radar Localisation of Non-palpable Breast lesions: Systemic Review and Pooled Analysis of 842 Cases'

  • Sun J, Henry D, Carr M, et al. "Feasibility of Axillary Lymph Node Localization and Excision Using Radar Reflector Localization"

  • Cox C, Russell S, Prowler V, et al. 'SCOUT 150 patient study: A Prospective, Single Arm, Multi-site, Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions during Excision'

04

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Sirius Medical is a spin-off from the Netherlands Cancer Institute, and we have our roots firmly embedded in the surgical clinic. At the Netherlands Cancer Institute, researchers recognised the need and opportunity to simplify and improve the localization technology for the surgical removal of breast cancers. This work resulted in the first development and clinical demonstration of magnetic seed localization. Sirius Medical perfected this technique and further developed this to a product, the Sirius Pintuition System. Sirius Pintuition is a new localization system that simply makes sense. Sirius Pintuition offers intuitive, precise, and directional guidance. True distance can be accurately detected by mm up to a distance of 50 mm. Directional guidance allow doctors to detect the magnetic seed within a specific field of view. Sirius Pintuition uses a permanent passive magnetic seed. Additional benefits of this approach is that the Sirius probe can be used with your own surgical steel instruments. Also a permanent magnetic seed will not fail, as the technology relies on intrinsic material properties of the seed that remain unaffected even when hypothetically damaged during use. The technology is CE marked for any soft tissue (Lymph and Primary) up to 180 days. A clinical study has demonstrated that the system is safe and performs as intended. Surgeons and radiologists show that they are satisfied with the system and prefer it over wire guided localization. Sirius Pintuition is available throughout Europe and multiple hospitals have started using the the Sirius Pintuition.

 

References:

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

05

Our navigation system builds upon the current gold standard wire-localization technique and uses real-time electromagnetic (EM) tracking to provide the surgeon with a pre-operatively defined tumor excision path that can be followed during surgery. After placement of the localization wire (fitted with an EM sensor), an EM-tracked ultrasound probe is used to generate a 3D computer model of the tumor. In the OR, this 3D model is displayed on a monitor along with the real-time position of an EM-tracked electrosurgical cauterizer and the surgeon uses this information to accurately navigate the excision of the tumor.       In a pilot clinical study involving 40 patients with an ultrasound visible, single, non-palpable lesion undergoing wire-localized lumpectomy, the navigation system was successfully used in all cases and there were no complications. The median operative time was 66 (44-119) minutes with the navigation system compared to 65 (34-158) minutes for the control group. The positive margin rate was 22.5% with navigation and 28.7% in the control group. Re-excision specimen contained residual disease in 14.3% of the navigation patients and 50% of the control group patients. The mean specimen volume removed was 95.4±73.5cm3 with navigation and 140.7±100.3cm3 for the control group.     The potential benefits of this system include (i) a reduction in the occurrence of cancer-positive margins, which reduces the number of additional surgeries required, the overall cost to the healthcare system, and the trauma experienced by the patient; and (ii) a reduction in the amount of healthy tissue excised, thereby improving cosmetic outcomes. 

 

References:

  • Ungi, T., Gauvin G., Lasso A., Yeo C. T., Pezeshki P., Vaughan T., et al. (2015). Navigated breast tumor excision using electromagnetically tracked ultrasound and surgical instruments. IEEE Transactions on Biomedical Engineering. 2016 Mar;63(3):600-6. doi: 10.1109/TBME.2015.2466591.

  • Gauvin, G., Ungi T., Lasso A., Walker R., Rudan J., Fichtinger G., et al. (2016). Safety and Feasibility Study for Real-Time Electromagnetic Navigation in Breast-Conserving Surgery. Computer Assisted Radiology and Surgery, 30th International Congress. 11(Suppl. 1), S106-7. Int J CARS (2016) 11(Suppl 1): 1. https://doi.org/10.1007/s11548-016-1412-5