The clinical trial landscape is set to expand with Edwards Lifesciences introducing The Continuity Study, designed to evaluate groundbreaking devices for blood pressure monitoring. Targeted to enhance accuracy and usability in vital sign measurement, this study encompasses multiple promising interventions. Regulatory and clinical teams should take note of this innovative effort.
In this article:
- Which devices are being investigated?
- What is the current status of the trial?
- Who is sponsoring this study?
Which devices are being investigated?
The Continuity Study will evaluate three distinct devices tailored for adult blood pressure monitoring:
- HemoSphere Vita Monitor: A device designed to display real-time hemodynamic information to clinicians, aiming for enhanced decision-making in patient care.
- VitaWave or VitaWave Plus Finger Cuff: These non-invasive cuffs are intended for individualized blood pressure measurement with reduced patient discomfort.
- ForeSight Large Sensors: Smart sensors that integrate with monitoring systems to supply continuous blood flow and pressure metrics.
The study seeks to understand how these tools can improve clinical outcomes and streamline practices in monitoring systems. The devices reflect advancements in technology meant to balance innovation with strict adherence to safety standards.
What is the current status of the trial?
The Continuity Study is officially listed as not yet recruiting. This means that while the protocol is prepared, patient enrollment has not commenced as of the time of this publication (October 14, 2025). Regulatory teams and clinical consultants can monitor updates via official sources such as ClinicalTrials.gov for enrollment announcements and timeline developments.
Who is sponsoring this study?
Edwards Lifesciences, the sponsor behind The Continuity Study, is a renowned medical technology company specializing in innovative solutions for cardiovascular disease and critical care monitoring. With decades of experience in medical device development, their involvement assures the trial’s adherence to rigorous regulatory guidelines and focus on patient safety.
Their objective aligns closely with unmet clinical needs, presenting devices that integrate precision and usability, which could impact quality of care positively across healthcare settings.
FAQ
1. What conditions are being studied?
The trial focuses on monitoring blood pressure in adult patients using advanced technological devices.
2. Is recruitment open now?
No, the study is listed as not yet recruiting. Updates on enrollment status should be tracked through official channels.
3. Where can I find detailed information?
The ClinicalTrials.gov study record linked at the end of this article offers exhaustive details about this trial.
Conclusion
The Continuity Study represents an important step in advancing blood pressure monitoring technology. Clinical, regulatory, and quality teams should stay informed about its progress—especially as recruitment begins and findings emerge. Edwards Lifesciences’ involvement offers confidence in regulatory compliance and device performance standards.
Disclaimer
This article is intended for informational purposes for medical device professionals and does not constitute legal advice. Decisions should align with current regulatory frameworks and official study updates.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07216573?term=medical+device