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 Veranex, we strive for excellence and quality in all our client-oriented services. We offer pathology services that include expert macroscopic and histologic evaluation. As with all 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 surgeons. Histopathological observations are thus evaluated in the context of clinical outcomes, imaging data, and macroscopic findings at the time of explanation so that they can be interpreted in a comprehensive and integrated manner.
Our pathology staff has years of hands-on experience and provides reliable and skilled services responsive to client needs.
In addition to routine histology of paraffin-embedded tissue samples with standard or special staining and immunohistochemistry, the pathology department also carries out resin sectioning for medical devices and hard tissues.
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 hematoxylin and eosin staining (HE&S)
- Frozen sectioning
- Special stains
- Cusps from prosthetic valves
- Soft devices or biomaterials (vascular conduits, artificial ureters, bladders, 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, and other tissues.
Specific immunolabeling is a very valuable ancillary method to visualize and quantify cell or tissue components. We perform immunohistochemistry for endothelial cells, collagen fibers, smooth muscle cells, myofibroblasts, and inflammatory cell populations and sub-populations, but we can also develop personalized protocols to fit your needs and endpoints.
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 maintenance of the tissue-implant interface, thereby enabling an accurate evaluation of the intimate interface between the biomaterial and implanted tissues.
- Heart valves
- Metallic stents
- Orthopedic implants
- Artificial cartilage
- Ophthalmic implants
We can take over the digitalization of histological slides, permanent archiving, telepathology, or quantitative measurements.
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 endpoints 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 will be suitable for regulatory purposes and for publishing.
Histopathological evaluations are conducted according to internal standard operating procedures and to the current highest professional and scientific standards in the spirit of ISO10993-Part 6: Test for Local Effects After Implantation. All evaluations are conducted in compliance with GLP and audited by the Quality Insurance Unit of Veranex.
Quantitative parameters (fibrous pannus thickness, remnants of the implanted biodegradable material, bone-implant contact, 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, and dental implants, but we will also apply customized measurements to fit your specific needs.
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 PowerPoint presentation
- Histomorphometry data
Additional Options Available
- 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