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vs-1 silicone implant leads new serial tube
Telectronics
Summary: The vs-1 silicone implant leads are used in cardiac pacing systems, primarily by cardiologists and electrophysiologists, for patients requiring atrial pacing. It is designed to provide reliable electrical conduction in cardiac procedures.
FDA Clearance Information
Pathway
510K
Number
K890350 ↗
Decision Date
February 2, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The vs-1 silicone implant leads by Telectronics were cleared through the FDA 510k pathway on February 2, 1989. It is classified as a Class 3 medical device, indicating a higher risk level requiring stringent regulatory controls.
What It Is
The vs-1 silicone implant leads are components of cardiac pacing systems, designed to deliver electrical impulses to the heart. These leads are made with silicone insulation and are used to ensure stable and reliable conduction of electrical signals. They are typically used in conjunction with pacemakers to manage arrhythmias by maintaining appropriate heart rhythms.
Clinical Applications
These leads are commonly used in cardiac electrophysiology and cardiology settings, particularly in procedures involving the implantation of pacemakers. They are suitable for patients with atrial fibrillation or other arrhythmias that require precise electrical pacing. The device is typically used in hospital settings, including cardiac catheterization labs and operating rooms.
Indications for Use
The vs-1 silicone implant leads are indicated for use in patients who require atrial pacing due to arrhythmias. This includes individuals with conditions such as atrial fibrillation or bradycardia, where maintaining a regular heart rhythm is critical.
Practical Considerations
The vs-1 leads are available in various lengths to accommodate different patient anatomies and procedural needs. They are compatible with most standard pacemaker systems. Clinicians should be familiar with the implantation technique and ensure proper lead positioning to optimize device performance.
Related Literature
The linked study compared two models of bipolar active fixation atrial leads, focusing on their pacing and sensing characteristics. It involved 19 patients and evaluated parameters such as pacing threshold and impedance. The study found differences in performance based on lead design, but was limited by its small sample size and short follow-up duration.
Frequently Asked Questions
What is vs-1 silicone implant leads used for?
The vs-1 silicone implant leads are used in cardiac pacing systems to help regulate heart rhythms in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in settings such as cardiac catheterization labs and operating rooms.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring atrial pacing due to arrhythmias such as atrial fibrillation or bradycardia.
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.