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intermedics lifeline tle endocardial
Intermedics
Summary: The Intermedics Lifeline TLE Endocardial is a Class III medical device used in cardiac care. It is typically utilized by cardiologists for managing heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K801172 ↗
Decision Date
December 1, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics Lifeline TLE Endocardial was cleared via the FDA 510(k) pathway on December 1, 1980. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Intermedics Lifeline TLE Endocardial is a cardiac device designed to be implanted in the heart's endocardial surface. It functions to regulate heart rhythms, providing electrical stimulation to maintain proper cardiac function. This device is crucial in the management of arrhythmias, ensuring that the heart beats at a regular pace.
Clinical Applications
This device is commonly used in the management of patients with arrhythmias, such as atrial fibrillation or ventricular tachycardia. It is typically implanted in a hospital setting, often in a cardiac catheterization lab or during a surgical procedure. Cardiologists and electrophysiologists are the primary specialists involved in its use, focusing on patients who require long-term rhythm management.
Indications for Use
The device is indicated for patients who have heart rhythm disorders that require regulation through electrical stimulation. It is suitable for those who have not responded to medication or other non-invasive treatments.
Practical Considerations
Considerations for this device include ensuring proper sizing and compatibility with the patient's anatomy. Implantation requires precise technique and is typically performed under fluoroscopic guidance to ensure accurate placement.
Frequently Asked Questions
What is the Intermedics Lifeline TLE Endocardial used for?
It is used to manage and regulate heart rhythms in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac care settings.
What are the FDA-cleared indications?
It is indicated for patients with heart rhythm disorders requiring electrical stimulation for rhythm management.
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.