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Evaluation procedure for endovascular implantation of a stent-graft with valve element in tricuspid valve insufficiency initiated in Germany
On November 9, 2020, in accordance with §137h Paragraph 6 SGB V, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for endovascular implantation of a stent-graft with valve element in tricuspid valve insufficiency within the framework of the early benefit assessment.
The evaluated product is TRICENTO, manufactured by the New Valve Technology GmbH. TRICENTO is intended for patients with severe tricuspid valve insufficiency who have corresponding symptoms, their general condition (physical performance, state of decompensation) gradually deteriorates and for which no surgical intervention is possible because of high surgical risk. The patients are in the advanced stages of the disease (NYHA III-IV).
Treatment with TRICENTO cannot be offered for the patients with anatomical peculiarities outside of the stent-graft specifications, a lung resistance >3 WU, a pressure in the right atrium >25mmHg, a pulmonary arterial blood pressure >50mmHg, and indications of an inferior pumping capacity of the right ventricle.
The full details in German can be found here.
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