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cross-seal suture-mediated vascular closure device system
Terumo Medical
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 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.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly following diagnostic or therapeutic catheterization procedures. It is indicated for one access site per leg, facilitating quicker hemostasis.
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.
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.