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model 2188 coronary sinus lead
Medtronic Vascular
Summary: The Model 2188 Coronary Sinus Lead is a cardiac pacing lead used in patients with heart failure requiring cardiac resynchronization therapy. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K961936 ↗
Decision Date
August 15, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 2188 Coronary Sinus Lead was cleared through the FDA 510(k) pathway on August 15, 1996. It is manufactured by Medtronic Vascular and classified as a Class III device.
What It Is
The Model 2188 Coronary Sinus Lead is a specialized cardiac pacing lead designed for placement in the coronary sinus to facilitate left ventricular pacing. It is part of a cardiac resynchronization therapy system, which aims to improve cardiac function in patients with heart failure by coordinating the contraction of the heart's ventricles. The lead is typically used in conjunction with other pacing leads to achieve optimal cardiac output.
Clinical Applications
This device is commonly used in the management of patients with heart failure, particularly those with dilated cardiomyopathy and conduction abnormalities such as left bundle branch block. It is typically used in electrophysiology labs and cardiac catheterization suites by cardiologists specializing in heart failure and electrophysiology. The patient population includes those with severe heart failure symptoms who are candidates for cardiac resynchronization therapy.
Indications for Use
The Model 2188 Coronary Sinus Lead is indicated for use in patients with heart failure who require cardiac resynchronization therapy to improve cardiac output and reduce heart failure symptoms. It is particularly useful in patients with conduction delays that affect the heart's ability to pump efficiently.
Practical Considerations
The lead is designed to be compatible with various cardiac resynchronization therapy devices and is typically available in multiple lengths to accommodate different patient anatomies. Placement requires careful technique to ensure proper positioning within the coronary sinus, and compatibility with the patient's existing cardiac device system should be verified.
Related Literature
The linked study investigated the use of a four-chamber pacing system in a 54-year-old man with severe congestive heart failure. The study demonstrated that using temporary leads, including the Model 2188 Coronary Sinus Lead, significantly improved cardiac output and reduced pulmonary capillary wedge pressure. While the study showed promising results, it was limited by its single-patient design and lack of long-term follow-up data.
Frequently Asked Questions
What is the Model 2188 Coronary Sinus Lead used for?
It is used for cardiac resynchronization therapy in patients with heart failure to improve cardiac function and reduce symptoms.
What specialties typically use this device?
Cardiologists and electrophysiologists specializing in heart failure and cardiac resynchronization therapy.
What are the FDA-cleared indications?
It is indicated for use in patients with heart failure requiring cardiac resynchronization therapy to improve cardiac output and reduce symptoms.
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.