📊 Evidence-Based Reference
Acqref Introducer Sheath
Acutus Medical
Summary: The AcqRef Introducer Sheath by Acutus Medical is a Class 2 medical device cleared by the FDA for use in embolization procedures. Key evidence highlights its utility in complex vascular interventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K192106 ↗
Decision Date ?
September 3, 2019
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The AcqRef Introducer Sheath was cleared by the FDA through the 510(k) pathway on September 3, 2019. It is manufactured by Acutus Medical and classified as a Class 2 device.
What It Is
The AcqRef Introducer Sheath is a medical device designed to facilitate the introduction of catheters and other instruments into the vascular system. It is primarily used in embolization procedures and other interventional cardiology applications.
FDA-Cleared Indications
- Used to introduce and guide compatible catheters or other intravascular instruments into the vascular system.
- Cleared for use during embolization procedures.
- Intended for use by trained clinicians in endovascular procedures requiring vascular access.
Clinical Applications
- Providing vascular access for catheter-based embolization
- Introducing delivery catheters used to treat selected arterial bleeding
- Providing access for embolization of aneurysms, arteriovenous malformations, or abnormal blood flow
- Supporting catheter access during other appropriately labeled endovascular interventions
Evidence Summary
The available literature includes 10 studies, with a mix of randomized controlled trials, prospective, and retrospective studies, spanning from 2021 to 2023.
Reported Outcomes
Published studies report the AcqRef Introducer Sheath as effective in facilitating vascular access during complex procedures. It has been used successfully in revascularization and thoracic endovascular aortic repair, demonstrating its versatility in clinical settings.
Safety Profile
Reported complications include challenges in advancing certain devices through the sheath and potential placement errors, as noted in specific case studies. Overall, the device is considered safe when used according to guidelines.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to fully understand the device's performance across diverse patient populations.
Practical Considerations
- The sheath size, length, and dilator configuration must match the planned catheter or device and the access vessel.
- Use is typically performed through percutaneous arterial or venous access with fluoroscopic or other image guidance.
- Operators should confirm compatibility with the guidewire, catheter, embolic-delivery system, and any contrast-injection requirements before use.
- Potential access-related complications include bleeding, hematoma, arterial or venous injury, thrombosis, infection, and embolization.
- MRI safety depends on the exact product configuration and whether the sheath remains in the patient; consult the current manufacturer labeling before MRI. The sheath is generally removed at the end of the procedure.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for AcqRef Introducer Sheath?
The AcqRef Introducer Sheath is indicated for use in embolization procedures and other interventional cardiology applications requiring vascular access.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful use in revascularization and thoracic endovascular aortic repair, highlighting its effectiveness in complex vascular interventions.
What complications have been reported?
Safety data indicate potential complications such as device advancement challenges and placement errors, though these are generally manageable with proper technique.
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.