Frequently Asked Questions

The KAI Membrane is composed of aseptically processed human placental membrane allografts (HPMAs), specifically consisting of both amnion and chorion layers. These layers contain naturally preserved placental factors, providing anti-inflammatory, antimicrobial, and tissue remodeling properties.

The membrane is applied epicardially after cardiopulmonary bypass and decannulation, prior to partial pericardial closure. It is strategically placed over critical heart areas (right atrium, right ventricle, and left ventricle), secured either with clips or topically positioned beneath the pericardium, making it adaptable for robotic and open procedures alike.

Clinical outcomes from the study include:

• Significant reduction (over four-fold) in post-operative atrial fibrillation (POAF) from 35.2% to 8.3%.
• Reduced need for inotropic support duration.
• Trend towards decreased ICU length of stay.
• No reported new-onset heart failure, stroke, or death within 30 days post-procedure.

The human placental tissue is aseptically processed, regulated under FDA guidelines as a Human Cellular and Tissue-Based Product (HCT/P). It adheres strictly to FDA 21 CFR 1271 and Section 361 of the Public Health Service (PHS) Act, ensuring thorough safety and screening protocols.

The study reported no adverse events directly related to the membrane usage, such as acute kidney injury, stroke, heart failure, or mortality within 30 days following the procedure.

Yes, training and samples are typically available upon request to facilitate understanding of membrane handling, placement technique, and integration into surgical practices.