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liverty tips access set
Bard Peripheral Vascular
Summary: The Liverty Tips Access Set is a medical device used for creating transjugular intrahepatic portosystemic shunts (TIPS) in patients with portal hypertension. It is typically used by interventional radiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K221440 ↗
Decision Date
May 31, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Liverty Tips Access Set was cleared through the FDA 510(k) pathway on May 31, 2022. It is manufactured by Bard Peripheral Vascular and classified as a Class 2 device under product code DYB.
What It Is
The Liverty Tips Access Set is designed for the creation of transjugular intrahepatic portosystemic shunts (TIPS), a procedure that helps manage complications of portal hypertension by connecting the portal and hepatic veins. The device features an ergonomic handle and a steerable cannula, allowing for precise navigation and placement within the liver vasculature. This design aims to enhance procedural efficiency and safety.
Clinical Applications
The device is primarily used in interventional radiology for patients with portal hypertension, often due to cirrhosis, who require a TIPS procedure to alleviate symptoms like variceal bleeding or refractory ascites. It is typically employed in hospital settings, particularly in tertiary care centers where complex liver procedures are performed. The device aids in improving patient outcomes by facilitating the creation of a shunt to reduce portal pressure.
Indications for Use
The Liverty Tips Access Set is indicated for use in patients with portal hypertension who need a transjugular intrahepatic portosystemic shunt (TIPS). This includes conditions such as variceal bleeding and refractory ascites, where reducing portal pressure is clinically beneficial.
Practical Considerations
The device is compatible with standard TIPS procedure equipment and may offer advantages in terms of steerability and ease of use due to its ergonomic design. Clinicians should be familiar with the handling of steerable cannulas and ensure compatibility with other procedural tools.
Related Literature
A 2023 study evaluated the safety and effectiveness of the Liverty Tips Access Set in a swine model, comparing it to the COOK Rosch-Uchida Transjugular Liver Access Set. The study found that the Liverty device was effective and feasible, with its steerable cannula providing enhanced control. However, the study was limited to an animal model, and further research in human subjects is needed to confirm these findings.
Frequently Asked Questions
What is the Liverty Tips Access Set used for?
It is used for creating transjugular intrahepatic portosystemic shunts (TIPS) in patients with portal hypertension.
What specialties typically use this device?
Interventional radiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with portal hypertension requiring a TIPS procedure, such as those with variceal bleeding or refractory ascites.
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.