VDyne Commences TriNova TTVR System’s TRIVITA US Pivotal Study

July 31, 2026—VDyne Inc. announced that the first patient has been enrolled in the TRIVITA United States investigational device exemption pivotal study of the company’s TriNova transcatheter tricuspid valve replacement (TTVR) system for the treatment for tricuspid regurgitation (TR).

According to the company, TRIVITA is a prospective, global, multicenter, randomized (1:1) controlled study designed to evaluate the safety and effectiveness of the TriNova TTVR system in patients with severe or greater tricuspid regurgitation who are suitable for valve replacement.

VDyne stated that the study, which will be conducted at up to 70 sites in the United States and Europe, will compare TriNova head-to-head with the commercially available Evoque TTVR system (Edwards Lifesciences).

The first patient was enrolled by Konstantinos Voudris, MD, Director, Center for Valve and Structural Heart Disease, at the Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital in Minneapolis, Minnesota.

Susheel Kodali, MD, and Nadira Hamid, MBBCh, serve as Global Coprincipal Investigators of the TRIVITA study.

“The benefits and importance of treating TR are quickly evolving as a growing number of patients seek treatment and TriNova represents a significant step forward in TR therapies, an outcome we intend to demonstrate through the United States pivotal study,” commented Dr. Kodali in VDyne’s press release. “Enrolling the first patient in the United States pivotal study brings hope for an improved standard of care.”

Dr. Kodali continued, “TriNova incorporates next-generation elements designed to offer unique side delivery and compatibility with tricuspid anatomy. The system is designed to operate independently of the leaflets and chordae, ensuring reliable annular anchoring and providing functional evaluation prior to final implantation.”

In addition to the TRIVITA pivotal trial, the company’s clinical development program evaluating the TriNova TTVR system includes the ongoing global VISTA and United States VISTA-US early feasibility studies, noted the VDyne press release.