đź“Š 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-coils procedures. Key evidence highlights its application in complex vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K171557 ↗
Decision Date
February 6, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The acqref introducer sheath was cleared through the FDA 510(k) pathway on February 6, 2018. 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-coils procedures to provide a stable conduit for device delivery.
Clinical Applications
Common clinical scenarios for the acqref introducer sheath include complex vascular interventions such as revascularization and thoracic endovascular aortic repair. It is used to enhance procedural efficiency and safety in challenging cases.
Evidence Summary
The available literature includes 10 peer-reviewed studies, with a mix of randomized controlled trials, prospective and retrospective studies, and case series. The studies span from 2021 to 2023, providing insights into the device's clinical applications.
Reported Outcomes
Published studies report that the acqref introducer sheath is effective in facilitating complex vascular procedures, such as revascularization of large-vessel occlusions and thoracic endovascular aortic repair. The device has been associated with improved procedural outcomes in challenging cases.
Safety Profile
Reported complications include difficulties in advancing certain occluders through the sheath and accidental placement issues during procedures. These highlight the need for careful handling and adherence to recommended guidelines.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to establish long-term outcomes and to explore the device's performance in 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-coils procedures and other complex vascular interventions.
What outcomes have been reported in clinical studies?
Studies have reported effective facilitation of complex vascular procedures, with improved procedural outcomes in challenging cases.
What complications have been reported?
Complications include difficulties in advancing occluders and accidental placement issues, emphasizing the need for careful handling.
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.