đź“Š Evidence-Based Reference
Cross-Seal Suture-Mediated Vascular Closure Device System
Summary: The Cross-Seal Suture-Mediated Vascular Closure Device System is used for closing femoral artery access sites post-catheterization. It is FDA-cleared for use with 8F to 18F sheaths. Key evidence includes a prospective trial assessing its effectiveness and safety.
FDA Clearance Information
Pathway ?
PMA
Number ?
P210017 ↗
Decision Date ?
September 26, 2023
Product Code ?
MGB Device, Hemostasis, Vascular
Device Class ?
Class 3
Evidence ?
0 studies
The Cross-Seal device received FDA clearance via the PMA pathway on September 26, 2023. It is manufactured by Terumo Medical and classified as a Class III device.
What It Is
The Cross-Seal Suture-Mediated Vascular Closure Device System is designed to deliver sutures percutaneously to close the common femoral artery access site. It is intended for use in patients undergoing catheterization procedures with sheath sizes ranging from 8F to 18F.
FDA-Cleared Indications
- Percutaneous delivery of sutures to close a common femoral artery access site.
- Use after diagnostic or interventional catheterization procedures performed with 8F to 18F sheaths.
- Use at one access site per leg.
- Reduction of time to hemostasis after femoral artery catheterization.
Clinical Applications
- Closure of a common femoral artery puncture after diagnostic catheterization.
- Closure of a common femoral artery access site after interventional catheterization.
- Closure of access sites created with 8F, 9F, 10F, 11F, 12F, 13F, 14F, 15F, 16F, 17F or 18F sheaths, when otherwise suitable.
- Femoral access-site closure at one treated access site per leg.
Evidence Summary
The available literature includes a prospective, multicenter, single-arm study and a clinical trial registered on ClinicalTrials.gov. These studies focus on the device's effectiveness and safety in achieving hemostasis post-procedure.
Reported Outcomes
Published studies report that the Cross-Seal device effectively achieves hemostasis at the femoral artery access site following procedures with large sheath sizes. The IDE trial demonstrated favorable outcomes in reducing time-to-hemostasis.
Safety Profile
Reported complications include vascular complications, which are a common concern with large-sheath technology. However, specific safety data from the studies are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of detailed safety outcomes and the need for further research to confirm long-term efficacy and safety. Additional studies with larger sample sizes and diverse populations are needed.
Practical Considerations
- The labeled sheath-size range is 8F to 18F; use outside this range is not included in the FDA indication.
- The device is intended for a common femoral artery access site and one access site per leg. Vessel location, puncture height, calcification and other anatomic factors should be assessed before deployment.
- It is a suture-mediated closure system and requires correct positioning, suture deployment and device removal according to the manufacturer’s instructions for use.
- The FDA record does not establish an MRI safety designation in the information provided. MRI conditions should be verified in the current labeling or with the manufacturer before scanning.
- Potential complications of femoral vascular closure devices include bleeding, hematoma, infection, arterial narrowing or occlusion, pseudoaneurysm, arteriovenous fistula and failure of hemostasis.
Frequently Asked Questions
What are the clinical indications for Cross-Seal Suture-Mediated Vascular Closure Device?
The device is indicated for closing the common femoral artery access site in patients undergoing catheterization procedures with 8F to 18F sheaths.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective hemostasis at the access site and reduced time-to-hemostasis following procedures with large sheath sizes.
What complications have been reported?
Reported complications include vascular complications associated with large-sheath technology, though specific data are not detailed in the provided evidence.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.