Pathology

IMMR is committed to being a world-leading, science-driven center of excellence in medical and biotechnology preclinical research. As part of the assessment of the safety, performance and efficacy of a new biomaterial or device, the Pathology Department of IMMR offers an integrated, comprehensive, state-of-the-art and GLP-compliant portfolio of services that includes sample processing, evaluation, interpretation and reporting.

 

Pathology is an essential component of the evaluation of device safety and performance in preclinical research and has a central position in regulatory guidance documents (ISO 10993, ASTM International, EMEA guidelines and FDA recommendations). Macroscopic and microscopic evaluation performed in a carefully selected large model provides critical information regarding biological responses to a medical device or biomaterial.

 

At IMMR, we strive for excellence and high quality in all our client-oriented services. We offer pathology services that include both expert macroscopic as well as histologic evaluation. As with all of our services, we are committed to delivering your results in a timely and cost-effective manner.

 

Protocol design, macroscopic assessment and tissue sampling are performed by pathology professionals in close collaboration with the surgeons. Histopathological observations are thus evaluated in the context of clinical outcomes, imaging data and macroscopic findings at the time of explantation so that they can be interpreted in a comprehensive and integrated manner.

 

Our pathology staff have many years of hands-on experience and provide reliable and skilled services in a manner that is responsive to our clients’ needs.

 

In addition to routine histology of paraffin-embedded tissue samples with standard or special staining and immunohistochemistry, the IMMR Pathology Department also carries out resin sectioning for medical devices and hard tissues.

Necropsy services

Necropsies and macroscopic evaluation are supervised by a certified senior veterinary pathologist.

 

General Histology Services

We offer the following routine histology services:

  • Paraffin embedding and sectioning
  • Routine HE&S staining
  • Frozen Sectioning
  • Special Stains

 

Applications:

  • Cusps from prosthetic valves
  • Soft devices or biomaterials (vascular conduits, artificial ureters, bladder, surgical sealants, patches etc.)
  • Target/distant organs (kidney, liver, lung or brain) for the assessment of systemic effects

 

Special stains are very useful in the qualitative assessment of histological sections, and complement HE&S as they specifically stain some components of normal or pathological tissues. We developed routine panels of special stains for cusps of prosthetic valves, cartilage, biomaterials or other tissues.

 

  • Immunohistochemistry

Specific immunolabelling is a very valuable ancillary method to visualize and quantify cells or tissue components. We perform immunohistochemistry for endothelial cells, collagen fibers, smooth muscle cells, myofibroblasts, or inflammatory cells populations and sub-populations, but we can also develop personalized protocols to fit your needs and end-points.

Specialized tissue-implants processing

  • MMA resin embedding
  • EXAKT® cutting and grinding
  • H&E and Masson Trichrome staining of resin sections

 

This highly-specialized technique is typically used for the evaluation of large and/or hard implants or soft/hard implants in undecalcified tissues. It allows to maintain tissue-implant, and therefore to perform an accurate evaluation of the intimate interface between the biomaterial and implanted tissues.

 

Applications:

  • Heart valves,
    Metallic stents
  • Orthopedic implants
  • Artificial cartilage
  • Ophthalmic implants
  • Etc.

Whole slide imaging

We can take over the digitalization of histological slides permanent archiving, telepathology or quantitative measurements.

 

Histopathological evaluation

The microscopic evaluation of your study will be performed by certified, experienced veterinary pathologists. The study pathologist will qualitatively describe and interpret the microscopic findings with regard to the study end-points, using international histological guidelines. A semi-quantitative score of severity with predetermined criteria will be applied. These criteria are defined to meet the specific aims of your study. The pathologist will also take remarkable microphotographs of representative findings from the study that are suitable for regulatory purposes and for publishing.

 

Histopathological evaluations are conducted according to internal standard operating procedures and to current highest professional and scientific standards in the spirit of ISO10993-Part 6: Test for Local Effects after Implantation. All evaluations can be conducted in compliance with Good Laboratory Practice (GLP) and audited by the Quality Insurance Unit of IMMR.

 

Morphometry

Quantitative parameters (fibrous pannus thickness, remnants of the implanted biodegradable material, bone-implant contact or vessel stenosis etc.) can be measured on histological sections with professional software. We use dedicated protocols for the histomorphometric evaluation of heart valves, stents, bone reconstruction, dental implants. But we will also apply customized measurements to fit your specific needs.

Pathology reporting

Our hallmark is clear, didactic and richly illustrated reports with annotated pictures.

 

The histopathology report includes:

  • Narrative description of microscopic changes
  • Qualitative and semi-quantitative assessment of microscopic changes
  • Individual data from all large models
  • Annotated representative microphotographs on a power point presentation
  • Histomorphometry data

 

In addition

  • The images can be professionally edited for publication-ready submission
  • An oral presentation of the pathological data and scientific discussion with the study pathologist and other members of the scientific staff can be organized upon request