Material Safety of Styrene-Block-Ethylene/Butylene-Block-Styrene Copolymers Used for Cardiac Valves: 6-Month In Vivo Results from a Juvenile Sheep Model.

ABSTRACT:

Objectives

To assess the in vivo 6-month safety of styrene-block-ethylene/butylene-block-styrene (SEBS) block copolymers material used to make cardiac valves.

Methods

Research-grade mitral valve prototypes made from SEBS29/SEBS20 copolymers (n = 7; 3 with heparin-coating) were implanted in juvenile sheep under cardiopulmonary bypass and kept for 6 months. No vitamin K antagonists were used. Anticoagulation included enoxaparin 1 mg/kg SC twice/day from day 1 until day 120 along with clopidogrel 300 mg once/day with food from day 1 until sacrifice. Safety measures included SEBS-related calcification, degradation, haemolysis, cytotoxicity, clinical pathology (biochemistry, complete blood count, coagulation), structural integrity, damage to surrounding tissue, overall animal hea

SUBMITTER: Ascione R 

PROVIDER: S-EPMC12365636 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature