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transjugular access set
Angiodynamics
Summary: The transjugular access set by Angiodynamics is used primarily for transjugular intrahepatic portosystemic shunt (TIPS) procedures. Key evidence highlights its feasibility and safety in clinical settings.
FDA Clearance Information
Pathway 510K
Number K964034 ↗
Decision Date May 6, 1997
Product Code DYB
Device Class Class 2
Evidence 0 studies
The transjugular access set was cleared by the FDA through the 510(k) pathway on May 6, 1997. It is manufactured by Angiodynamics and classified as a Class 2 device.
What It Is
The transjugular access set is a medical device designed to facilitate access to the hepatic and portal venous systems via the jugular vein. It is primarily used in the creation of transjugular intrahepatic portosystemic shunts (TIPS) for patients with portal hypertension.
Clinical Applications
This device is commonly used in interventional radiology for patients requiring TIPS, particularly those with complications from portal hypertension such as variceal bleeding or refractory ascites.
Evidence Summary
The literature includes 15 studies, comprising feasibility studies, RCTs, and case series, published between 2021 and 2024. These studies evaluate the device's safety, efficacy, and technical feasibility.
Reported Outcomes
Published studies report that the transjugular access set is effective in facilitating TIPS procedures, with successful portal vein access being a critical outcome. The device's ergonomic design and steerable cannula have been highlighted as beneficial features in achieving procedural success.
Safety Profile
Reported complications include challenges in portal vein targeting and potential risks associated with venous puncture. However, studies indicate that the device is generally safe when used by experienced clinicians.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and to compare the device with alternative access methods.
Frequently Asked Questions
What are the clinical indications for transjugular access set?
The transjugular access set is indicated for use in transjugular intrahepatic portosystemic shunt (TIPS) procedures, particularly in patients with portal hypertension-related complications.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful portal vein access and effective TIPS creation, with the device's design aiding in procedural success.
What complications have been reported?
Safety data from evidence indicate complications such as difficulties in portal vein targeting and risks associated with venous puncture, though these are generally manageable.
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.