đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as an atrial pacing lead in a cardiac pacing system for patients requiring atrial pacing.
Clinical Applications
- Implantation as part of a permanent pacemaker system that provides atrial pacing.
- Delivery of electrical pacing impulses from a compatible pacemaker generator to the atrium.
- Use during cardiac pacing procedures when an atrial lead is clinically indicated.
Practical Considerations
- The lead must be matched with a compatible pacemaker generator and implanted using the manufacturer’s instructions.
- Available lead length and configuration should be selected for the patient’s anatomy and intended lead route.
- Implantation requires confirmation of appropriate atrial position and acceptable electrical measurements, including sensing and pacing thresholds.
- MRI safety cannot be determined from the available FDA record; the lead should be treated as not established as MRI-conditional unless current labeling confirms otherwise.
- Potential complications include lead dislodgement, fracture, insulation damage, infection, bleeding, cardiac perforation, abnormal pacing, and the need for revision or removal.
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.