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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 access safety and efficacy.
FDA Clearance Information
Pathway
510K
Number
K100615 ↗
Decision Date
March 30, 2010
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Arstasis Access System was cleared by the FDA through the 510(k) pathway on March 30, 2010. It is manufactured by Arstasis and classified as a Class 2 device.
What It Is
The Arstasis Access System is designed to facilitate arterial access for endovascular procedures. It employs a unique mechanism to minimize trauma during vascular entry, aiming to improve patient outcomes.
Clinical Applications
Commonly used in procedures requiring precise arterial access, such as embolization and other endovascular interventions. It is particularly useful in scenarios where minimizing vascular trauma is critical.
Evidence Summary
The available literature includes five studies, comprising various study types such as RCTs and registries. The studies span from 2020 to 2021, focusing on safety and efficacy post-intervention.
Reported Outcomes
Published studies report that the Arstasis Access System is effective in achieving vascular access with reduced complications. The device has shown promise in improving procedural success rates and minimizing access-related issues.
Safety Profile
Reported complications include minor access site bleeding and hematoma formation. Overall, the device is associated with a favorable safety profile, with low incidence of serious adverse events.
Evidence Limitations
The evidence is limited by the small number of studies and lack of long-term follow-up data. Further research is needed to confirm the long-term safety and efficacy of the device in diverse patient populations.
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 endovascular interventions.
What outcomes have been reported in clinical studies?
Studies have reported effective vascular access with reduced complications and improved procedural success rates.
What complications have been reported?
Safety data indicate minor complications such as access site bleeding and hematoma, with a low incidence of serious adverse events.
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.