đź“Š Evidence-Based Reference
Transjugular Access Set
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 ?
510(k)
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.
FDA-Cleared Indications
- Provides transjugular access to the hepatic and portal venous systems during percutaneous interventional procedures.
- Used to facilitate access for creation of a transjugular intrahepatic portosystemic shunt.
Clinical Applications
- Transjugular access during TIPS creation for portal hypertension.
- Catheter and guidewire access to the hepatic veins and portal vein during image-guided portosystemic shunt procedures.
Reported off-label uses
- Transjugular access for selected hepatic venous or portal venous diagnostic and therapeutic procedures other than TIPS, when determined appropriate by the treating specialist.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The set is introduced through the internal jugular vein and advanced under fluoroscopic or other appropriate imaging guidance.
- Available components, lengths, and diameters should be selected to match the patient's venous anatomy, access route, and compatible guidewires or catheters.
- Use requires sterile technique and management of potential access-site complications such as bleeding, hematoma, infection, thrombosis, or venous injury.
- MRI safety depends on the specific components and materials in the set; the current device labeling and MRI conditions should be reviewed before scanning.
- Contraindications and precautions include unsuitable jugular or central venous anatomy, uncorrected coagulopathy, active infection at the access site, and inability to safely perform the planned procedure.
Procedures that use this device
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.