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Cephea Early Feasibility Study

The purpose of this study is to evaluate an investigational device called the Cephea Mitral Valve System, which is designed for the treatment of a diseased, damaged, or malfunctioning mitral valve. Specifically, the study aims ...


Other

COMPASSION S3 Post Approval

The SAPIEN 3 THV System was recently approved for use in patients with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention. The objective of ...


Other

RenataMedical_PTC-0009 (Minima Stent)

The objective of the clinical investigation is to access device performance and the initial clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis ...


Pulmonary hypertension

Pulmonary Arterial Hypertension: Treprostinil Palmitil Inhalation Powder in Pulmonary Arterial Hypertension (INS1009)

The purpose of this study is to evaluate an investigational drug called treprostinil palmitil inhalation powder (TPIP) for the treatment of pulmonary arterial hypertension (PAH). The study aims to determine the effectiveness and tolerability of ...


Other

MITRAL II PIVOTAL TRIAL (Mitral Implantation of Transcatheter Valves)

The purpose of this study is to establish the safety and effectiveness of a device called the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific ...