Safety
Proprietary Processing PROPRIETARY PROCESSING FOR SAFETY AND QUALITY The amniotic sac from which BioXclude is derived exists at the interface of the mother and developing child. It forms a protective barrier that must evade detection from the mother’s immune system to prevent an adverse foreign body response that would threaten the existence of the child. With over 1.8 million amnion-chorion allografts distributed to date, no cases of rejection or adverse reaction have been reported, allowing applications for the majority of your patient population. This proprietary process safely and gently separates placental tissues, cleans and reassembles layers, and then dehydrates the tissue to preserve the key elements associated with healing. Once through processing, the allografts are terminally sterilized (SAL 10-6). The result is a minimally manipulated dehydrated deepithelialized amnion-chorion allograft membrane which:
Note: BioXclude allografts are human tissue products, and appearance may vary between donors. Variations in color (tan to light brown), opacity, and thickness are typical due to the nature of human tissue. These variations are normal and do not alter the efficacy of the membrane. |