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Arstasis Access System
Arstasis
Summary: The Arstasis Access System is a medical device used for vascular access. It is primarily used in procedures requiring arterial access. Key evidence includes studies on safety and efficacy in endovascular interventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K102728 ↗
Decision Date ?
October 7, 2010
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Arstasis Access System was cleared by the FDA via the 510(k) pathway on October 7, 2010. It is manufactured by Arstasis and classified as a Class 2 device under product code DYB.
What It Is
The Arstasis Access System is designed to facilitate arterial access for various endovascular procedures. It aims to provide a reliable and efficient method for vascular entry, minimizing complications associated with traditional access techniques.
FDA-Cleared Indications
- Facilitates percutaneous arterial access for endovascular procedures.
Clinical Applications
- Obtaining arterial access for diagnostic angiography.
- Obtaining arterial access for catheter-based embolization procedures.
- Obtaining arterial access for other endovascular interventions.
Evidence Summary
The available literature includes five studies, encompassing various study types such as RCTs and registries. These studies span from 2020 to 2021, providing insights into the device's safety and efficacy in clinical practice.
Reported Outcomes
Published studies report that the Arstasis Access System is effective in achieving reliable vascular access with a low incidence of access-related complications. The device has been associated with successful procedural outcomes in endovascular interventions.
Safety Profile
Reported complications include access site bleeding and hematoma formation, although these are relatively infrequent. The studies highlight the device's safety profile as favorable compared to traditional access methods.
Evidence Limitations
The evidence base is limited by a small number of studies, with some lacking detailed outcome data. Further research is needed to establish long-term safety and efficacy, as well as to explore its use in diverse patient populations.
Practical Considerations
- The available FDA record identifies the device by product code DYB but does not provide detailed size, sheath, needle, or catheter-compatibility specifications in the supplied text.
- Use requires image-guided vascular access and standard sterile technique by trained clinicians.
- The access site and technique should be selected based on the target procedure, vessel anatomy, anticoagulation status, and risk of bleeding or vascular injury.
- MRI safety information is not established by the supplied FDA record. Confirm the specific device labeling before MRI, especially if any component remains in or near the patient.
- Potential access-related complications include bleeding, hematoma, pseudoaneurysm, arterial dissection, thrombosis, infection, and damage to nearby structures.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Arstasis Access System?
The device is indicated for use in procedures requiring arterial access, such as embolization and other endovascular interventions.
What outcomes have been reported in clinical studies?
Studies have reported successful vascular access with low complication rates, demonstrating the device's efficacy in clinical settings.
What complications have been reported?
Safety data indicate that complications such as access site bleeding and hematoma are possible but occur infrequently.
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.