VDyne has enrolled and treated the first patient in the TRIVITA US investigational device exemption (IDE) pivotal study of the TriNova transcatheter tricuspid valve replacement (TTVR) system.
Being conducted at up to 70 sites across the US and Europe, the study will compare the TriNova device directly with the Edwards EVOQUE TTVR system.
The initial treatment took place at the Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, US, led by Center for Valve and Structural Heart Disease director Dr Konstantinos Voudris.
The prospective, multi-centre, randomised (1:1) controlled trial aims to evaluate both the effectiveness and safety of TriNova in patients diagnosed with severe or greater tricuspid regurgitation (TR) eligible for valve replacement procedures.
It marks a new phase in the clinical development of the TriNova system, which is still under investigation and has not received approval for commercial sale in any country.
VDyne chairman and CEO Mike Buck said: “Initiating our TRIVITA US IDE pivotal study represents an important milestone for VDyne following years of innovation by our dedicated team. The trial reflects our continued commitment to advancing treatment options for patients with TR and evaluating TriNova’s potential role in the evolving standard of care.
“As we rapidly activate new investigational sites and build enrolment momentum in TRIVITA, as well as continue enrolment in the ongoing VISTA US and VISTA Global trials, we are moving closer to our ambition of establishing TriNova as the preferred treatment option for TR patients globally.”
VDyne focuses on the clinical development of its TTVR system for TR.
In April 2026, the US Food and Drug Administration granted an investigational device exemption , enabling the company to initiate a pivotal trial of its TTVR system for severe TR treatment.
