The medical device industry is observing an anticipated development as Shanghai Bomaian Medical Technology Co., Ltd. announces a clinical trial investigating the safety and effectiveness of vascular closure devices used for femoral artery hemostasis. This research focuses on devices developed by Bomaian Medical and Cordis US Corp, targeting individuals undergoing femoral artery puncture procedures.
The trial is registered on ClinicalTrials.gov, with no commencement date yet and recruitment marked as “Not yet recruiting.” Professionals in clinical practice, medical device regulation, and quality assurance should follow this study for insights into vascular closure device advancements and clinical applicability.
What is the purpose of this clinical trial?
This trial aims to validate and compare the safety and effectiveness of vascular closure devices used during femoral artery hemostasis following puncture procedures. Hemostasis is critical to reducing post-procedure complications such as bleeding and infection while ensuring faster recovery. The investigation intends to ensure compliance with medical device regulations and provide thorough performance data on these products.
Which devices are under study?
Two major devices are featured in this study:
- Bomaian Vascular Closure Device: Manufactured by Shanghai Bomaian Medical Technology Co., Ltd., this device highlights innovations from a growing player in the medical technology field.
- MynxGrip Vascular Closure Device: Developed by Cordis US Corp, this device represents an established option often favored for femoral artery closure.
Both devices are the study’s focus, aiming for comparative analysis to outline their safety profiles and clinical efficacy.
How might this study impact healthcare professionals?
Healthcare professionals should anticipate potential changes in procedural guidelines based on outcomes from this trial. The following areas could be affected:
- Device Adoption: Physicians may gain evidence-based insights into device selection for specific clinical situations.
- Regulatory Standards: New regulatory pathways could emerge depending on trial results.
- Patient Outcomes: Enhanced recovery protocols and reduced complication rates aligned with validated device safety.
The study’s findings could contribute significantly to both clinical practice and the regulatory approval landscape.
Frequently Asked Questions
- When does patient recruitment start?
The trial is labeled “Not yet recruiting.” No confirmed recruitment date is available. - Who sponsors this trial?
The trial is sponsored by Shanghai Bomaian Medical Technology Co., Ltd. - Where can I find more details?
Detailed trial registration is available on ClinicalTrials.gov.
Conclusion and takeaways
This clinical trial represents a critical step toward advancing vascular closure technologies and reinforces the industry’s commitment to addressing procedural risks effectively. Professionals in clinical operations, quality management, and device regulatory affairs have an opportunity to stay connected to evolving innovations that may shape future practices.
Disclaimer
This article is designed for informational purposes. It does not provide legal or clinical advice. Always refer to regulatory authorities or healthcare policies for official guidance.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07279220?term=medical+device