The TricValve® Transcatheter Bicaval Valves System is indicated for relief of tricuspid insufficiency in patients with symptomatic heart disease who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy.
The P+F Products + Features GmbH conducts two clinical trials which are designed to investigate the safety and efficacy of the TricValve® Transcatheter Bicaval Valves System for patients suffering from severe Tricuspid Regurgitation.
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Intended use of the Vienna Aortic Valve SE – Self-expandable Transcatheter Valve System is in symptomatic patients with severe aortic stenosis (SSAS) with the required anatomical criteria who are at intermediate to high surgical risk and accepted for transcatheter aortic valve implantation (TAVI) by the Heart Team.
The clinical trial for VIVA is a prospective, non-randomized, single arm, multicenter, multinational two-stage FIH feasibility followed by pivotal study in patients with SSAS
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