Clinical data

The Magseed® marker has been clinically proven to be a safe, accurate and effective treatment

Used in more countries around the world than any other seed technology the Magseed® marker has been subject to numerous regulatory approvals, clinical trials, new product evaluations and appeared in numerous peer-reviewed papers.

Here you can read these clinical assessments in full and see how Magseed® marker compares to alternative technologies.

Simons et al (2021)

Summary

This study from MD Anderson Cancer Center demonstrates the efficacy of the Magseed® marker for breast lymph node marking post Neoadjuvant Chemotherapy

Key points

  • 17 different radiologists placed 50 Magseed® markers into clipped lymph nodes
  • 100% placed first attempt, 88% within the node
  • 10 surgeons removed the Magseed® marked node, with 100% retrieval rate
  • Removal of clipped nodes can be accomplished safely and effectively with Magseed® marker localization.

Gera et al (2020)

Summary

This meta analysis found that Magseed is a non-inferior, reliable and effective radiation-free localisation alternative to WGL, widely accepted by physicians as it decouples radiology and surgery schedules.

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Key points

  • Covered 16 Magseed® studies, featuring 1,559 patients
  • Overall re-excision rate of 11.19%
  • Successful localization rate of 99.86%

Miller et al (2020)

Summary

This study was the largest non-radioactive seed series in the world, demonstrating a highly successful Magseed® marker program implementation.

Key points

  • 842 Magseed® markers placed in 673 patients by 9 radiologists and removed by 6 surgeons at 6 different locations
  • 136 lymph node localizations included
  • Overall re-excision rate of 15%
  • 99.5% Magseed® marker retrieval rate

Singh et al (2020)

Summary

This prospective single center study from MD Anderson Cancer Center concludes that the Magseed® marker is safe and effective for localisation and excision of non-palpable breast lesions

Key points

  • 124 seeds placed in 93 patients
  • All Magseed® markers placed within 10mm of the target
  • 100% Magseed® retrieval rate
  • 91% Negative margin rate

Micha et al (2020)

Summary

This study from the Royal Marsden Hospital investigates patient and clinician satisfaction and clinical outcomes for Magseed® localization, demonstrating a clinician preference for Magseed® and a reduction in patient anxiety

Key points

  • 124 Magseed® markers compared against 168 WGL cases
  • Patients treated with Magseed® reported less anxiety than those treated with wires
  • Clinicians reported greater ease of use with Magseed® compared to wires
  • Re-excision rates were the same between groups but the excised Magseed® specimens were statistically significantly smaller

Zatecky et al (2020)

Summary

This multi-center concludes that the Magseed® marker is a reliable marker for breast tumors and pathological axillary node localization in breast cancer patients.

Key points

  • Included 41 Magseed® markers placed in 39 patients at 3 different institutions
  • 7 of the markers were placed in TAD procedures
  • 100% Magseed® retrieval rate
  • 14.7% re-excision rate

Kühn et al (2020)

Summary

This study from Charité hospital in Berlin, Germany concludes that the Magseed® marker is superior to WGL for patient comfort and reduces operative time.

Key points

  • Significantly lower pain levels were reported after Magseed® localization compared to wires, including no pain in movement or sleep
  • Magseed® showed a reduced operative time (14 mins) compared to wires (17.5)
  • Magseed® operative time expected to decrease with experience

Martinez et al (2020)

Summary

This study investigated the feasibility and efficacy of Magseed®, concluding it to be simple to use and that it consents short lumpectomy time, whilst improving the care pathway and organization of both radiological and surgical teams

Key points

  • 20 Magseed® markers placed across 19 patients
  • Magseed reduced incision to tumor resection time to an average of 11 minutes
  • Patients reported very low pain levels at Magseed insertion (2/10)

Zacharioudakis et al (2019)

Summary

This study evaluates the early adoption of the Magseed® marker compared to hookwire lesion localisation

Key points

  • 100% intraoperative success for identifying and retrieving Magseed® markers
  • No statistically significant difference between the Magseed® marker and hookwire re-excision rate
  • Study includes the surgeons first Magseed® marker cases
  • The Magseed® marker allowed surgical approach and incision placement independent of the localisation process

Thekkinkattil et al (2019)

Summary

This study shows that the Magseed® marker is a safe, easy technique with a short learning curve, with efficient use of clinical resources

Key points

  • No Magseed® marker migration
  • 14.8% re-excision rate overall, over 12 surgeons
  • No re-excisions for invasive carcinoma required
  • Clinicians found Magseed® marker quicker and easier than a wire
  • All Magseed® markers localised, even in very large breasts

Greenwood et al (2019)

Summary

This study shows that Magseed® marker localization is a safe, nonradioactive way to accurately localize axillary lymph nodes preoperatively

Key points

  • 35 patients received Magseed® marker node localization
  • 100% surgical success with 97% Magseed® marker retrieval rate
  • One Magseed® marker was misplaced in the OR, however no regulatory issue with magnetic technology

Hersi et al (2019)

Summary

This study demonstrates accurate lesion localisation and SLN detection with the combined use of the Magseed® marker and Magtrace® lymphatic tracer

Key points

  • No Magseed® marker migration was noted and low tumour resection volumes were documented (CRR - 1.49)
  • Peritumoral injection of the Magtrace® lymphatic tracer was utilised and all SLNB’s were successful
  • Clinicians reported the method was easier than hook-wire localisation
  • Hospital scheduling was improved

Pohlodek et al (2019)

Summary

This study demonstrates the combined use of the Magseed® marker and Magtrace® lymphatic tracer for lesion localisation and SLNB

Key points

  • All lesions were successfully excised with tumour-free margins
  • SLNB was successful in all patients
  • The Magtrace® lymphatic tracer was injected subareolar pre or post operatively
  • No interference between the Magseed® marker and Magtrace® lymphatic tracer signals was noted

Harvey et al (2018)

Summary

This study shows that the Magseed® marker can be accurately placed, demonstrates no migration and is detectable in all sizes and depths of breast tissue

Key points

  • The Magseed® marker was detectable in all breast sizes (maximum 2.6kg)
  • There were no complication or safety issues
  • No Magseed® marker migration was noted

Lamb et al (2018)

Summary

This study – featuring 188 patients – shows that Magseed® marker localisation has the potential to replace conventional wire needle localisation

Key points

  • 96.7% of Magseed® markers placed accurately first attempt
  • 100% successful Magseed® marker retrieval rate
  • No complications associated with the Magseed® marker

Chacko et al (2018)

Summary

This study demonstrates the benefits of implementing a Magseed® marker program into a large hospital facility.

Key points

  • The Magseed® marker allows for decoupling of the localisation and day of surgery
  • The Magseed® marker bypasses regulatory disadvantages associated with radioactive seed localisation
  • The Magseed® marker is 'indestructable', non-radioactive and poses no danger to clinical staff
  • A reduction in OR delays was noted
  • Great radiology flexibility was achieved

Price et al (2017)

Summary

This study from UCSF shows that the Magseed® marker provides an effective means for preoperative localisation of non-palpable breast lesions

Key points

  • The Magseed® marker was adopted as standard of care after a two week evaluation
  • The first 4 months of Magseed® marker cases are reported on
  • 100% placement and retrieval success
  • Seed placement was extremely accurate
  • Overall 12% re-excision rate

Additional references

If you would like to read additional literature relating to the Magseed® marker and its safety, effectiveness and clinical results, please get in touch and we will be happy to assist you.