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laserdish polyurethane ventricular lead w trailing
Telectronics Pacing Systems
Summary: The Laserdish Polyurethane Ventricular Lead is a cardiac device used for pacing the ventricles in patients with arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway 510K
Number K900645 ↗
Decision Date August 8, 1990
Product Code DTB
Device Class Class 3
Evidence 0 studies
The Laserdish Polyurethane Ventricular Lead was cleared through the FDA 510(k) pathway on August 8, 1990. It is manufactured by Telectronics Pacing Systems and is classified as a Class III device.
What It Is
The Laserdish Polyurethane Ventricular Lead is a specialized cardiac lead designed for ventricular pacing. Made from durable polyurethane, it is engineered to deliver electrical impulses to the heart's ventricles, helping to maintain an adequate heart rate in patients with arrhythmias. The lead is typically implanted via a minimally invasive procedure and connects to a pacemaker device.
Clinical Applications
This device is commonly used in the management of patients with bradycardia or heart block, conditions where the heart beats too slowly. It is typically utilized in cardiology and electrophysiology departments within hospitals. Patients who have experienced heart attacks or have congenital heart defects may benefit from this device to ensure proper heart function.
Indications for Use
The Laserdish Polyurethane Ventricular Lead is indicated for patients who require ventricular pacing due to conditions like bradycardia or heart block. It helps in maintaining a regular heart rhythm in patients whose natural pacemaker is not functioning properly.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with most pacemaker devices. Proper placement and secure fixation are crucial for optimal performance, and clinicians should be trained in lead implantation techniques.
Frequently Asked Questions
What is the Laserdish Polyurethane Ventricular Lead used for?
It is used for ventricular pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring ventricular pacing due to conditions like bradycardia or heart block.
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.