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Thoraflex hybrid prosthesis (THP): the profile.
Expert Review of Medical Devices 2024 March 3
INTRODUCTION: With the incidence of thoracic aortic disease on the rise, total arch replacement (TAR) with frozen elephant trunk (FET) remains the gold-standard management strategy due to optimal results. Several FET devices exist commercially on the global market. However, the mainstay and most commonly used and reported device is the Thoraflex Hybrid Prosthesis (THP), with several recent reports suggesting its superiority.
AREAS COVERED: This review aims to collate and summarize the evidence in the literature on the clinical outcomes of TAR with FET using THP, with a focus on mortality, neurological complications, endoleak, distal stent-induced new entry (dSINE), aortic remodeling, coagulopathy and graft kinking. In addition, the design features of THP is discussed, and an overview of market competitors is also highlighted.
EXPERT OPINION: THP consistently demonstrates its effectiveness in treating complex thoracic aortic pathology through favorable clinical outcomes, which can be attributed to its unique and innovative design. Rates of early mortality ranged 0.6-14.2%, neurological complications 0-25%, endoleak 0-8.4% and dSINE 0-14.5%, with minimal incidence of graft kinking and coagulopathy. Aortic remodeling is favorable and comparable to competitors. All this evidence solidifies THP as the leading FET device, particularly when combined with appropriate patient selection and surgical planning.
AREAS COVERED: This review aims to collate and summarize the evidence in the literature on the clinical outcomes of TAR with FET using THP, with a focus on mortality, neurological complications, endoleak, distal stent-induced new entry (dSINE), aortic remodeling, coagulopathy and graft kinking. In addition, the design features of THP is discussed, and an overview of market competitors is also highlighted.
EXPERT OPINION: THP consistently demonstrates its effectiveness in treating complex thoracic aortic pathology through favorable clinical outcomes, which can be attributed to its unique and innovative design. Rates of early mortality ranged 0.6-14.2%, neurological complications 0-25%, endoleak 0-8.4% and dSINE 0-14.5%, with minimal incidence of graft kinking and coagulopathy. Aortic remodeling is favorable and comparable to competitors. All this evidence solidifies THP as the leading FET device, particularly when combined with appropriate patient selection and surgical planning.
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