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Clinical Trial Update Status
TricValve® - Transcatheter Bicaval Valve System
The TricValve® – Transcatheter Bicaval Valve 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.
P+F Products + Features GmbH conducted two clinical trials which were designed to investigate the safety and efficacy of the TricValve® Transcatheter Bicaval Valve System for patients suffering from severe Tricuspid Regurgitation. Based on the results of the Tricus and Tricus Euro studies, we obtained the CE mark. We are conducting the ongoing Tricus Registry Study as a Clinical Follow-Up to further clarify the mid- and long-term safety of the TricValve® Transcatheter Bicaval Valve System.
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Vienna Aortic Valve SE – Self-expandable Transcatheter Valve System
Intended use of the Vienna Aortic Valve SE – Self-expandable Transcatheter Valve System is in symptomatic patients with symptomatic 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
The Vienna Aortic Valve SE System (VIVA)
A Two -Stage First in Human (FIH) Feasibility / Pivotal Study
