ClearCoast™ MRI System and Tissue Container

ClearCoast™ MRI System and Tissue Container
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The ClearCoast™ MRI System represents clear progress in intraoperative assessment of the surgical margin as part of breast-conserving surgery. The proven technology of the ClearCoast™ MRI System helps surgeons make a quick and precise intraoperative assessment of the surgical margin, and remove the tumour while preserving as much of the healthy surrounding tissue as possible.

Benefits

Easy operation and simple interpretation
The intuitive and easy operation together with the simple interpretation of the colour-coded results eliminate the need for the user to have detailed technical, histopathological or radiological expertise. Trained, non-medical staff, can operate the ClearCoast™ MRI System.

Fewer follow-up operations
The ClearCoast™ MRI System offers surgeons increased confidence in detecting positive margins (R1 situations) during the initial breast-conserving surgery. As a result, the number of repeated surgeries can be reduced by up to 80%.1

Improved quality of life
A reduction of repeated surgeries can be a significant relief for the patients - both physically and psychologically. General surgical risks as well as worries and fear can be reduced accordingly.2 The necessary adjuvant therapies can be introduced without delay.3

Cost savings
In 15% to 35% of breast-conserving surgery cases a re-excision is required.3 Every follow-up operation that is saved reduces costs and freed-up operating theatre capacity can be put to use elsewhere.

Clear vision
Vacuum technology removes air from the ClearCoast™ Tissue Container. This puts the tissue in direct contact with the MRI scanning surface. Blind spots caused by air bubbles are reduced. Aids to fix the tissue are redundant.

Better aesthetic outcome
The aesthetic outcome can be one of the most important aspects of breast-conserving surgery for many patients.4 An accurate intraoperative assessment of the margin can allow the surgeon to make the excision with as little safety distance from the tumour as possible. Every follow-up intervention saved also has a positive influence on the result in itself.

[1] Thill, M. et al., Magnetic resonance imaging system for intraoperative margin assessment for DCIS and invasive breast cancer using the ClearSight™ system in breast conserving surgery – Results from a postmarketing study, J Surg Oncol. 2022, 125(3): 361-368. doi: 10.1002/jso.26721. Epub 2021 Nov 1. PMID: 34724205
[2] Maloney, B. et al., Review of methods for intraoperative margin detection for breast conserving surgery, J Biomed Opt. 2018, 23(10): 1-19
[3] Walijee, J. et al., Predictors of re-excision among women undergoing breast-conserving surgery for cancer, Ann Surg Oncol. 2008; 15(5): 1297-303
[4] Catsman, C. et al., The COSMAM TRIAL a prospective cohort study of quality of life and cosmetic outcome in patients undergoing breast conserving surgery, BMC Cancer. 2018, 18(1): 456

Product Details

  • Quick margin assessment: Process time comparable to – or less than - frozen section procedure analysis.
  • Mobile MRI, which offers the advantages of MRI technology in any surgical environment.
  • Shielded system without ionising radiation. No additional apparatus, equipment or a special room are needed and any precautions or measurements required. In addition, no precautions or measurements are required.
  • The use of contrast media is not necessary. The associated potential for allergic reactions or other side-effects can be avoided and patient preparation time can be reduced.
  • Preserve the integrity and quality of the tissue sample so that the histopathological assessment can subsequently be carried out unimpeded.[2]

Technical Data

Manufacturer

  • Clear-Cut Medical LTD, 5 David Fikes ST., Rehovot, 7632805, Israel

Ordering Information

Article numberMarkingDelivery unit (VPE)
CC00 ClearCoast™ MRI System 1 pcs
CTC10 ClearCoast™ Tissue Container 10 pcs

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