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Novel Pericardial Tissue Demonstrates Significant Improvement in Resistance to Calcification over Commercial Tissues Using Rabbit Intramuscular Model

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RESILIA™ Tissue Demonstrates Significant Improvement in Calcification Over Commercial Tissues Using Rabbit Intramuscular Model

Hao Shang, Steven M. Claessens, Bin Tian and Gregory A. Wright

Edwards Lifesciences LLC, One Edwards Way, Irvine, California USA 92614

 

RESILIA tissue is treated bovine pericardial tissue transformed by a novel integrity-preservation technology.

This novel technology incorporates two new proprietary features: stable capping and glycerolization.

Stable Capping permanently blocks free aldehydes and glycerolization prevents further exposure to these aldehydes by eliminating the need to store the tissue in aldahyde-based preservatives.

Valves made with RESILIA tissue are sterilized with EO and stored in dry conditions.

 

Calcification Study Design

The purpose of the study is to evaluate the calcification potential of RESILIA tissue against porcine tissue from MOSAIC (MDT) and bovine pericardial tissue from Trifecta (STJ). Following is the study design:

30 New Zealand white rabbits, age 6-8 weeks.

Samples are 6mm discs of RESILIA tissue, porcine tissue from MOSAIC (commercial source), bovine pericardium from Trifecta (commercial source) and glutaraldehyde treated bovine pericardium (positive control).

Tissue discs are implanted intramuscularly along the back of the same rabbit for 60 days. The positions of the discs are randomized.

Calcium is quantified by ICP-OES.

Tissue morphology and immuno-response are examined by histology.

Mann-Whitney method is used to compare the median of the calcium for each group.

Results: Calcification and Histology

RESILIA tissue showed significantly (p<0.05) lower measured calcium content than both porcine AOA and BP Linx, demonstrating 95% and 96% reductions, respectively.

RESILIA tissue elicited less of an inflammatory response indicated by the reduction in macrophage/giant cell infiltrates (blue stain and cell counts).

Tissue calcification is observed in all of the groups except RESILIA by von Kossa stain (brown stain).

The Journey Continues…

To further evaluate the findings seen in the rabbit model, RESILIA valve and PERIMOUNT valve are randomized and implanted in 45 juvenile sheep (<6 mo of age) in the mitral position for a total of 8 months. The results are consistent with findings seen in the rabbit study. Specifically, RESILIA tissue valves have significantly lower pressure gradient and calcium content than the PERIMOUNT valve.

Furthermore, RESILIA valves are evaluated in an early clinical study of 20 patients with one year follow up, demonstrating excellent valve performance, durability, and safety.

Limitations

The implanted tissue discs are subject to a static environment. A dynamic environment would better simulate the clinical use.

Long term clinical study is needed to establish the relationship between the pre-clinical results and clinical outcomes.

Conclusions

RESILIA tissue can reduce calcification by 95% in comparison with commercially available tissues in the intramuscular rabbit model.

Less inflammatory response is observed for RESILIA tissue through histology.

No clinical data are available which evaluate the long-term impact of the above Edwards Lifesciences tissue technologies in patients.

For professional use. See instructions for use for full prescribing information, including  indications, contraindications, warnings, precautions, and adverse events.

CAUTION – Investigational device. Limited by Federal (United States) law to investigational use.

This product has not been approved for marketing in the United States and is not available for commercial sale in the United States.

Edwards, Edwards Lifesciences, the stylized E logo, RESILIA, ThermaFix, and PERIMOUNT are trademarks of Edwards Lifesciences Corporation. MOSAIC is trademark of Medtronic Inc. Trifecta is trademark of St. Jude Medical, Inc. 

© 2016 Edwards Lifesciences Corporation. All rights reserved.

 

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