This news marks an important development for medical professionals monitoring carotid artery disease. A Post-Market Clinical Follow-up (PMCF) study involving the PRECISE PRO Rx Nitinol Stent System is scheduled to begin soon. Although recruitment has not yet commenced, the study aims to evaluate the safety and effectiveness of the device for patients with carotid artery stenosis.
In this article:
- What is the scope of the study?
- What do we know about the PRECISE PRO Rx?
- Why does this matter?
- Frequently Asked Questions
- Implications for clinical practice
- Disclaimer
- Official announcement link
What is the scope of the study?
Sponsored collaboratively by Cordis Corporation and Rede Optimus Hospitalar SA, the PMCF study is designed to collect post-market evidence, focusing on real-world performance and long-term safety of the PRECISE PRO Rx Nitinol Stent System in patients with carotid artery stenosis. As of October 2025, the study remains in the planning phase with recruitment listed as “Not Yet Recruiting.” Details about the study timeline, specific demographics, and procedural protocols are expected to follow.
What do we know about the PRECISE PRO Rx?
The PRECISE PRO Rx Nitinol Stent System is categorized as a medical device for use in carotid artery disease management. According to the manufacturer, the system is engineered for optimal durability, flexibility, and reliable placement within stenotic carotid arteries. This study could provide additional verification, aligning with requirements for post-market surveillance under MDR and similar regulatory frameworks.
Key features of the device:
- Nitinol construction to enhance adaptability.
- Designed to address carotid artery stenosis effectively.
- Claims of minimizing restenosis rates and procedural complications, pending verification.
Why does this matter?
Carotid artery stenosis is a critical condition that significantly elevates the risk of ischemic stroke. With stroke being one of the leading causes of mortality and long-term disability worldwide, effective devices like the PRECISE PRO Rx play a vital role in interventional strategies.
PMCF studies are not only required under regulatory bodies such as MDR but are also key for validating claims made by device manufacturers. The initiation of this study represents an ongoing commitment to patient safety and evidence-based practice.
Clinicians, regulatory specialists, and quality teams should monitor progress, as the findings may influence future procedural guidelines for carotid artery disease management.
Frequently Asked Questions
- Who sponsors the study?
The study is sponsored by Cordis Corporation and Rede Optimus Hospitalar SA. - What condition is being studied?
The study focuses on carotid artery stenosis. - What is the intervention?
The intervention involves the use of the PRECISE PRO Rx Nitinol Stent System. - Is recruitment active?
No. Recruitment is listed as “Not Yet Recruiting.”
Implications for clinical practice
Professionals in clinical, regulatory, and quality sectors should anticipate further publications and reports detailing study results. It is essential to stay updated to assess whether the eventual findings shape or confirm existing guidelines for carotid artery disease intervention. Additionally, early-stage awareness may help healthcare providers prepare for integrating any updated recommendations into practice.
Disclaimer
This article is for informational purposes only and should not be considered legal or clinical advice. Always consult applicable regulations and standards before acting.
Official announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07204678?term=medical+device