Published on October 5, 2025: A new clinical trial has put the spotlight on an innovative transcatheter mitral valve repair device named CathHELIX™, designed for patients with functional mitral regurgitation (FMR). Recruiting is underway for this promising intervention, backed by HVR Cardio Oy.
The trial seeks to assess the safety and efficacy of using the CathHELIX™ system to repair the mitral annulus in cases of degenerative or functional mitral valve regurgitation.
What changed?
The CathHELIX™ transcatheter system introduces a minimally invasive solution for mitral valve regurgitation, tackling both functional and degenerative types. This novel device is the focus of a recruiting clinical trial aimed at evaluating its potential as a breakthrough repair option. The trial is being supported by HVR Cardio Oy, the device manufacturer.
Who is affected?
Patients diagnosed with mitral valve regurgitation (MVR)—particularly those with functional mitral regurgitation—stand to benefit from advancements like the CathHELIX™ system. The trial also holds significance for healthcare providers, quality teams, and regulatory professionals monitoring new device interventions for cardiovascular conditions.
Clinical trial details
According to ClinicalTrials.gov, the enrolling study focuses on using CathHELIX™ for transcatheter mitral valve repair. The trial will involve qualified participants diagnosed with mitral valve regurgitation, whether degenerative or functional.
Manufacturer support
HVR Cardio Oy is leading the trial and aims to bring CathHELIX™ to regulatory and clinical validation. Their focus lies in demonstrating safety and performance in a controlled setting.
Intended impact
The CathHELIX™ system promises reduced procedural invasiveness compared to traditional surgical approaches. It may enhance outcomes for patients unfit for surgery or looking for alternatives.
How to enroll
Interested participants can find the detailed study and enrollment criteria on ClinicalTrials.gov under the identifier NCT07188233.
FAQ
1. What is the CathHELIX™ system?
CathHELIX™ is an advanced medical device designed for transcatheter repair of the mitral valve in patients with functional and degenerative regurgitation.
2. Which conditions does the trial target?
The study includes subjects with either functional mitral regurgitation or degenerative mitral regurgitation.
3. Who is conducting the clinical trial?
HVR Cardio Oy, the device manufacturer, is sponsoring the clinical investigation.
4. Where can I find the full study details?
Comprehensive information is accessible via ClinicalTrials.gov under the study identifier NCT07188233.
Conclusion
The CathHELIX™ system opens new pathways for mitral valve repair, offering hope to patients while advancing minimally invasive cardiac interventions. Providers and quality assurance teams should monitor this trial for updates on safety and performance.
Disclaimer
This article is intended for educational purposes and does not constitute legal or regulatory advice. For specific guidance, consult a qualified professional in medical device regulation.
Full announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07188233?term=medical+device