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high performance tips
Surgin Surgical Instrumentation
Summary: High performance tips by Surgin Surgical Instrumentation are used in portal vein procedures. Key evidence highlights their role in managing complications like hepatic encephalopathy in TIPS procedures.
FDA Clearance Information
Pathway
510K
Number
K943102 ↗
Decision Date
July 28, 1994
Product Code
HQC
Device Class
Class 2
Evidence
0 studies
The high performance tips were cleared by the FDA via the 510k pathway on July 28, 1994. Manufactured by Surgin Surgical Instrumentation, they are classified as Class 2 devices.
What It Is
High performance tips are surgical devices designed for use in portal vein procedures, particularly in Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedures. They facilitate the creation of a shunt between the portal and systemic venous systems.
Clinical Applications
These devices are commonly used in patients with cirrhosis to manage complications such as variceal bleeding and portal hypertension. They are integral in procedures aiming to reduce portal pressure and prevent further complications.
Evidence Summary
The literature includes 15 studies, with a mix of study types including meta-analyses and case series, spanning from 2024 to 2025. These studies explore the efficacy and safety of TIPS procedures using high performance tips.
Reported Outcomes
Published studies report that high performance tips are effective in managing portal hypertension and reducing variceal bleeding in cirrhotic patients. They are associated with improved survival rates in high-risk patients when used preemptively.
Safety Profile
Reported complications include hepatic encephalopathy, which remains a significant concern with a prevalence of 35 to 50% in TIPS procedures. The risk of complications varies based on the indication for TIPS.
Evidence Limitations
Current evidence is limited by the variability in study designs and patient populations. Further research is needed to standardize outcomes and explore long-term safety and efficacy in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for high performance tips?
High performance tips are indicated for use in portal vein procedures, particularly in managing complications of cirrhosis such as variceal bleeding and portal hypertension.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved survival rates and effective management of portal hypertension and variceal bleeding in high-risk patients.
What complications have been reported?
Safety data from evidence indicates a significant risk of hepatic encephalopathy, with prevalence rates between 35 to 50% in patients undergoing TIPS procedures.
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.