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percutaneous introducer for vena cava filter syst
B. Braun Vena-Tech
Summary: The percutaneous introducer for vena cava filter system by B. Braun Vena-Tech is a device used for the placement of vena cava filters. It is primarily used in patients requiring prevention of pulmonary embolism. Key evidence includes studies on its use in complex vascular access scenarios.
FDA Clearance Information
Pathway
510K
Number
K932921 ↗
Decision Date
August 30, 1993
Product Code
DTK
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on August 30, 1993. It is manufactured by B. Braun Vena-Tech and classified as a Class 2 medical device.
What It Is
The percutaneous introducer for vena cava filter system is designed to facilitate the insertion of vena cava filters into the inferior vena cava. It is intended for use in patients at risk of pulmonary embolism, providing a minimally invasive option for filter placement.
Clinical Applications
This device is commonly used in clinical scenarios where patients are at risk of developing pulmonary embolism, such as those with deep vein thrombosis. It is particularly useful in cases where traditional anticoagulation therapy is contraindicated.
Evidence Summary
The available literature includes 11 studies, comprising case series and other observational studies, published between 2009 and 2021. These studies explore various aspects of the device's application in complex vascular access situations.
Reported Outcomes
Published studies report successful use of the device in facilitating percutaneous interventions in challenging vascular access cases. Outcomes include effective placement of vena cava filters and successful management of patients with interrupted inferior vena cava.
Safety Profile
Reported complications include technical challenges associated with vascular access, as highlighted in case series. However, specific adverse events directly related to the device are not extensively detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the observational nature of the data. Further research is needed to establish long-term outcomes and safety profiles in larger patient populations.
Frequently Asked Questions
What are the clinical indications for percutaneous introducer for vena cava filter syst?
The device is indicated for the placement of vena cava filters in patients at risk of pulmonary embolism, particularly when anticoagulation therapy is not suitable.
What outcomes have been reported in clinical studies?
Studies report successful filter placement and management of complex vascular access cases, with effective prevention of pulmonary embolism.
What complications have been reported?
Safety data from evidence indicate technical challenges in vascular access, but specific adverse events related to the device are not extensively reported.
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.