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lifeline tle traebecular lodging elec
Intermedics
Summary: The Lifeline TLE Trabecular Lodging Elec is a medical device used primarily in the placement of inferior vena cava (IVC) filters. It is typically utilized by interventional radiologists or vascular surgeons to prevent pulmonary embolism in at-risk patients.
FDA Clearance Information
Pathway
510K
Number
K792300 ↗
Decision Date
June 4, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Lifeline TLE Trabecular Lodging Elec was cleared through the FDA 510(k) pathway on June 4, 1980. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Lifeline TLE Trabecular Lodging Elec is a specialized medical device designed for the insertion and secure placement of IVC filters. These filters are used to capture blood clots and prevent them from reaching the lungs, thus reducing the risk of pulmonary embolism. The device aids in the precise deployment of the filter within the vena cava, ensuring optimal positioning and effectiveness.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly relevant for patients who are at high risk of developing venous thromboembolism but cannot be managed with anticoagulation therapy. Typical scenarios include trauma patients, those undergoing major surgery, or individuals with a history of deep vein thrombosis. The device is used in hospital settings, often in catheterization labs or operating rooms.
Indications for Use
The FDA indications suggest that the device is intended for patients who require protection from pulmonary embolism due to blood clots. It is particularly useful for individuals who cannot take blood thinners or have contraindications to anticoagulation therapy.
Practical Considerations
Clinicians should be aware of the device's compatibility with various IVC filter models. Proper sizing and positioning are crucial for effectiveness and minimizing complications. Familiarity with the deployment technique is essential for successful outcomes.
Frequently Asked Questions
What is Lifeline TLE Trabecular Lodging Elec used for?
It is used for the placement of IVC filters to prevent pulmonary embolism in patients at risk of blood clots.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients who need protection from pulmonary embolism and cannot use anticoagulation therapy.
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.