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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
510K
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.
Clinical Applications
Commonly used in procedures requiring vascular access, the AcqRef Introducer Sheath is utilized in embolization and other complex interventions where precise catheter placement is critical.
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.
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.