A ground-breaking clinical trial targeting calcific Peripheral Artery Disease (PAD) will soon commence as FastWave Medical collaborates with Rede Optimus Hospitalar SA and Medical Metrics Diagnostics, Inc. The trial focuses on the FastWave Artero™ Peripheral IVL System, aiming to evaluate its safety and effectiveness in treating moderate to severe calcific PAD.
Announced on October 7, 2025, this study is under protocol registration and has yet to start recruiting participants. It addresses a vital unmet need in vascular medicine, building anticipation among clinical, quality, and regulatory professionals worldwide.
In this article:
- What changed?
- What are the trial’s highlights?
- What is the FastWave Artero System?
- FAQs
- What are the implications?
- Disclaimer
- Additional information
What changed?
The FastWave Artero™ Peripheral IVL System trial signals progress in tackling advanced calcific lesions associated with PAD. The study is registered on ClinicalTrials.gov and awaits regulatory clearance before participant enrollment begins. Vascular and interventional specialists should monitor this trial closely, as it could reshape treatment paradigms for PAD patients.
What are the trial’s highlights?
Study sponsors and collaborations
FastWave Medical, working alongside Rede Optimus Hospitalar SA and Medical Metrics Diagnostics, Inc, leads this trial. Together, they aim to deliver insights critical for device validation under existing medical device regulatory frameworks.
Scope and design
The trial will explore the FastWave Artero™ Peripheral IVL System’s ability to manage moderate to severe artery calcification, targeting safety and effectiveness as primary endpoint measures. This initiative aligns with continued efforts to optimize care for peripheral artery disease.
What is the FastWave Artero System?
The FastWave Artero™ Peripheral IVL System is a device designed to disrupt calcific vascular deposits using intravascular lithotripsy (IVL) technology. PAD-specific interventions focus on mitigating vascular resistance caused by calcium buildup, improving performance and treatment outcomes for patients.
Manufacturers of the FastWave Artero System emphasize the importance of device precision in delivering safe arterial care, particularly for complex cases of calcific disease.
FAQs
1. What condition does the trial target?
The study focuses on Peripheral Artery Disease (PAD) with moderate to severe calcifications.
2. Who is conducting the study?
The trial is sponsored by FastWave Medical, Rede Optimus Hospitalar SA, and Medical Metrics Diagnostics, Inc.
3. Is recruitment open?
No, recruitment has not started yet, and the trial is awaiting further regulatory steps before initiation.
4. What technology does the device use?
The FastWave Artero™ Peripheral IVL System utilizes intravascular lithotripsy (IVL) to address calcific arterial blockages effectively.
What are the implications?
Trials like these play a key role in advancing device innovation aligned with stringent regulatory guidelines. PAD affects global populations, with limb-threatening consequences when untreated. For clinical teams, validating novel devices is essential for aligning safety, performance, and efficacy claims.
This specific trial could pave the way for broader adoption of IVL methods, offering specialists new tools for treating complex calcific lesions while fulfilling regulatory criteria.
Disclaimer
This blog post is intended solely for informational purposes targeting clinical and regulatory professionals. It does not constitute legal or medical advice. Always consult appropriate regulatory guidelines and experts.
Additional information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07209085?term=medical+device