The efficacy of anti-calcification treatment of bioprosthetic heart valves remains unclear. We used urazole and glutamate to neutralize the free aldehyde and some solvents to reduce the phospholipid content in the bovine pericardial tissue.
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If your medical device is in any other class apart from class I, you will have to provide the Notified body with proof that your product fulfils the essential requirements of the respective CE directives. The medical devices of Class III hold the highest risk.
We provide Tissues Services for the heart valve industry at best prices. We procure bovine and porcine tissue for use in heart valve leaflets. boardboardboardboardboard