đź“‹ FDA Reference
modified ancor hi-flex unipolar active fix lead
Tpl-Cordis
Summary: The Modified Ancor Hi-Flex Unipolar Active Fix Lead is a cardiac pacing lead used in cardiac electrophysiology to help manage arrhythmias. It is typically used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K885240 ↗
Decision Date
February 10, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on February 10, 1989. Manufactured by Tpl-Cordis, it is classified as a Class III device under product code DTB.
What It Is
The Modified Ancor Hi-Flex Unipolar Active Fix Lead is a specialized cardiac lead designed for unipolar pacing. It features an active fixation mechanism that allows for secure attachment to the heart tissue, ensuring reliable electrical conduction. This device is used in conjunction with pacemakers to deliver electrical impulses to the heart, helping to regulate heart rhythms in patients with arrhythmias.
Clinical Applications
This device is commonly used in the treatment of patients with bradycardia or other arrhythmias requiring pacing. It is typically utilized in hospital settings, particularly in cardiac catheterization labs or electrophysiology suites. Cardiologists and electrophysiologists are the primary specialists who implant these leads, often in patients who require long-term cardiac pacing support.
Indications for Use
The FDA indications for this device include its use in patients who require cardiac pacing due to arrhythmias such as bradycardia. It is suitable for patients who need a reliable method to maintain heart rhythm, especially when other treatments are not effective.
Practical Considerations
The lead is designed to be compatible with most modern pacemaker systems. It is important to ensure proper sizing and placement during implantation to avoid complications. Clinicians should be familiar with the active fixation mechanism to ensure secure attachment to the myocardium.
Frequently Asked Questions
What is the Modified Ancor Hi-Flex Unipolar Active Fix Lead used for?
It is used for cardiac pacing in patients with arrhythmias, particularly bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring cardiac pacing due to arrhythmias such as 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.