VDyne Launches Pivotal TRIVITA Study, Treats First Patient with TriNova™ Transcatheter Tricuspid Valve Replacement System
VDyne Inc., a privately held medical device company focused on advancing structural heart therapies, has reached an important milestone in the development of its innovative TriNova™ transcatheter tricuspid valve replacement (TTVR) system. The company announced the successful enrollment and treatment of the first patient in its pivotal TRIVITA U.S. Investigational Device Exemption (IDE) clinical trial, marking the beginning of a global study designed to evaluate TriNova as a next-generation treatment for patients suffering from severe tricuspid regurgitation (TR).
The launch of the TRIVITA study represents a significant advancement for VDyne as it seeks to expand treatment options for one of the most challenging and historically underserved forms of valvular heart disease. The trial will directly compare the TriNova system with the commercially available Edwards EVOQUE™ TTVR system in a randomized head-to-head evaluation, providing valuable evidence regarding the safety and effectiveness of the investigational device.
Advancing Treatment for Tricuspid Regurgitation
Tricuspid regurgitation is a progressive heart valve disorder in which the tricuspid valve fails to close properly, allowing blood to flow backward into the right atrium. The condition can lead to debilitating symptoms including fatigue, swelling of the legs and abdomen, liver congestion, reduced exercise tolerance, heart failure, and ultimately increased mortality if left untreated.
Historically, patients with severe TR have had limited therapeutic options. Many are considered too high-risk for open-heart surgery because of advanced age or multiple medical conditions. The emergence of minimally invasive transcatheter valve therapies has transformed the treatment landscape, offering new hope for patients who previously had few viable options.
VDyne’s TriNova system has been specifically engineered to address the unique anatomical and procedural challenges associated with replacing the tricuspid valve through a catheter-based approach.
TRIVITA Trial Officially Begins
The initiation of the TRIVITA trial (ClinicalTrials.gov Identifier: NCT07516444) officially begins VDyne’s pivotal clinical program designed to support future regulatory submissions.
The prospective, randomized, controlled, multicenter study will enroll patients diagnosed with severe or greater tricuspid regurgitation who are considered suitable candidates for transcatheter valve replacement.
Participants will be randomized on a 1:1 basis to receive either:
- The investigational TriNova TTVR system
- The commercially available Edwards EVOQUE TTVR system
This direct comparison is intended to generate robust clinical evidence regarding the relative safety, procedural success, and clinical performance of the two technologies.
The study is expected to involve up to 70 investigational centers across the United States and Europe, making it one of the most comprehensive evaluations of a transcatheter tricuspid valve replacement system conducted to date.
First Patient Successfully Treated
The first patient enrolled in the TRIVITA study underwent treatment at the Allina Health Minneapolis Heart Institute located at Abbott Northwestern Hospital in Minneapolis, Minnesota.
The procedure was performed by Dr. Konstantinos Voudris, MD, PhD, Director of the Center for Valve and Structural Heart Disease, who successfully implanted the TriNova device as part of the landmark clinical trial.
Treating the first patient marks a major achievement for VDyne and establishes momentum for patient enrollment across additional clinical sites that are expected to join the study in the coming months.
Company Leadership Highlights Important Milestone
Mike Buck, Chairman and Chief Executive Officer of VDyne, described the initiation of the pivotal trial as the culmination of years of engineering innovation and clinical preparation.
According to Buck, beginning the TRIVITA study demonstrates the company’s continued commitment to improving treatment options for patients living with tricuspid regurgitation while generating high-quality evidence to support broader adoption of the TriNova system.
He emphasized that VDyne is rapidly activating additional investigational sites and expects enrollment to accelerate alongside its ongoing VISTA clinical studies. The company believes these combined programs will move TriNova closer to becoming a preferred treatment option for patients requiring transcatheter tricuspid valve replacement worldwide.
Buck also noted that the pivotal study reflects VDyne’s long-term strategy of delivering innovative structural heart technologies that address unmet clinical needs through minimally invasive therapies.
Addressing an Increasing Clinical Need
Awareness of tricuspid regurgitation has grown substantially over the past decade as clinicians recognize its impact on patient quality of life and long-term cardiovascular outcomes.
Although once considered a relatively neglected valve disease, severe TR is now increasingly treated with catheter-based technologies as evidence continues to demonstrate meaningful improvements in symptoms, functional capacity, and quality of life.
As more patients are diagnosed and referred for intervention, physicians are seeking devices capable of safely accommodating the complex anatomy of the tricuspid valve while providing durable valve replacement.
VDyne believes TriNova was specifically designed to meet these clinical demands.
Innovative Features of the TriNova System
The TriNova transcatheter tricuspid valve replacement system incorporates several next-generation design features intended to improve procedural performance and patient outcomes.
Unlike some existing technologies, the system has been engineered to accommodate the challenging anatomy of the tricuspid valve through an innovative side-delivery approach.
Among its notable design characteristics are:
- Compatibility with diverse tricuspid valve anatomies
- Side-delivery implantation approach
- Reliable annular anchoring
- Functional assessment before final deployment
- Independence from native valve leaflets and chordae
These features are intended to simplify implantation while improving procedural precision and long-term valve stability.
By functioning independently of the native leaflets and supporting chordal structures, TriNova aims to reduce procedural complexity while ensuring secure positioning within the tricuspid annulus.
Clinical Leaders Express Confidence
Dr. Susheel Kodali, incoming Co-Director of the Heart Valve Center at NYU Langone Medical Center and Study Chairman as well as Global Co-Principal Investigator for the TRIVITA study, emphasized the growing importance of developing new therapies for tricuspid regurgitation.
According to Dr. Kodali, increasing numbers of patients are seeking treatment for TR, making continued innovation in valve replacement technologies increasingly important.
He stated that TriNova represents a significant advancement in transcatheter therapies through its next-generation engineering and unique implantation strategy.
Dr. Kodali noted that the pivotal study will evaluate whether these technological innovations can translate into improved clinical outcomes and potentially establish a higher standard of care for patients with severe tricuspid regurgitation.
He further highlighted the system’s design advantages, including reliable annular fixation and the ability to evaluate valve function before permanent implantation.
Encouraging Early Clinical Experience
Dr. Nadira Hamid, Director of Interventional Echocardiography at Minneapolis Heart Institute and Scientific Director of the Echocardiography Core Laboratory at Minneapolis Heart Institute Foundation, also serves as Global Co-Principal Investigator of the TRIVITA study.
She noted that initiation of the pivotal trial represents another important milestone in expanding treatment options for patients with severe tricuspid regurgitation.
Dr. Hamid highlighted encouraging findings generated during earlier feasibility studies conducted in the United States, Europe, Australia, and Canada.
According to her, these investigations have demonstrated promising preliminary safety and device performance, providing confidence as the clinical program advances into its pivotal stage.
She expressed enthusiasm for continued enrollment as investigators gather additional evidence supporting the potential benefits of the TriNova system.
Building on Earlier Feasibility Studies
The TRIVITA pivotal study builds upon an extensive clinical development program that has progressively evaluated TriNova in patients with tricuspid regurgitation.
Current clinical investigations include:
- VISTA U.S. Early Feasibility Study (NCT05848284)
- VISTA Global Early Feasibility Study (NCT05797519)
- TRIVITA U.S. IDE Pivotal Study (NCT07516444)
The earlier VISTA studies have provided valuable insights into procedural safety, device deployment, and early patient outcomes. Data from these investigations have informed refinements to both the device and procedural techniques, laying the foundation for the larger pivotal trial.
The initiation of TRIVITA represents the next critical step toward establishing the safety and effectiveness necessary for future regulatory review.
As enrollment expands across North America and Europe, VDyne expects the TRIVITA study to generate comprehensive evidence supporting the role of TriNova in treating severe tricuspid regurgitation. The randomized comparison against an established commercial device is expected to provide meaningful clinical insights into device performance, procedural outcomes, and patient benefit.
With multiple clinical studies progressing simultaneously and increasing physician interest in transcatheter therapies for tricuspid valve disease, VDyne is positioning TriNova as a next-generation solution designed to address one of structural heart medicine’s most significant unmet needs. If successful, the company’s clinical program could pave the way for broader adoption of minimally invasive tricuspid valve replacement and offer new hope for patients who currently have limited treatment options.
About VDyne Inc.
VDyne Inc. is a privately held medical device company based in Maple Grove, Minnesota, developing a transcatheter tricuspid valve replacement (TTVR) system for the treatment of tricuspid regurgitation.
VDyne’s TTVR system is currently under clinical investigation and is not approved for commercial sale in the United States or any other jurisdiction.
For more information, please visit www.vdyne.com.