In Vitro and In Vivo biocompatibility evaluation of a left atrial appendage device: An ISO 10993-Based Safety Assessment

Background: The left atrial appendage (LAA) occluder is a durable medical device that will stay inside your body and come into contact with blood and heart tissue for a long period of time (i.e., greater than 30 days). Before patients can use the device, we must determine how well it works inside you for an extended period of time by completing an extensive evaluation of its biological safety under the ISO 10993 standard (International Standards Organization).
Objective of Study: This study will provide a thorough evaluation of the biocompatibility of the LAA occlusion device to meet the relevant requirements for long-term contact with blood under the ISO 10993 standards.
Methods:  A complete biocompatibility test strategy was developed based on the amount of time (i.e., length of time) that the LAA occlusion device will be in contact with tissue (i.e., heart tissue) and blood. The studies will use both polar and non-polar solvents to prepare device extracts (i.e., imitate the way it would be used in the environment) to perform the evaluations described below. The evaluations included cytotoxicity (ISO 10993-5), cutaneous irritation (ISO 10993-23), sensitization (ISO 10993-10), hemocompatibility (ISO 10993-4), and pyrogenicity and systemic toxicity (ISO 10993-11).
Results: The LAA Occluder demonstrated no evidence of cytotoxic effects, did not induce any dermal irritation or sensitization in the patient's dermis. Hemocompatibility studies from in vivo blood tests proved that there would be no adverse reactions to the blood component(s) when interacting with the LAA occluder. The device extracts showed no signs of pyrogenicity and acute systemic toxicity.
Conclusion: Based on the LAA Occluder's extensive biocompatibility evaluation, it has been found that they comply with all applicable ISO 10993 standards, therefore providing strong evidence of the LAA occluders' clinically acceptable long-term safety for use in clinical practice.