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implantable endocardial screw-in elec
Oscor
Summary: The implantable endocardial screw-in electrode by Oscor is a cardiac device used for pacing and sensing in patients with heart rhythm disorders. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K791732 ↗
Decision Date
September 19, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on September 19, 1979. It is manufactured by Oscor and classified as a Class III device under product code DTB.
What It Is
The implantable endocardial screw-in electrode is a cardiac device designed to be implanted into the heart muscle to provide electrical stimulation and sensing. It features a screw-in mechanism that ensures stable attachment to the endocardial surface, which is crucial for effective pacing and sensing. This device is typically used in conjunction with pacemakers or defibrillators to manage arrhythmias.
Clinical Applications
This device is commonly used in the management of patients with bradycardia or other arrhythmias requiring pacing. It is often utilized in electrophysiology labs and cardiac surgery settings. Cardiologists and electrophysiologists implant these electrodes in patients who need long-term cardiac rhythm management, including those with heart block or sick sinus syndrome.
Indications for Use
The implantable endocardial screw-in electrode is indicated for patients who require cardiac pacing due to arrhythmias such as bradycardia. It is suitable for individuals who need reliable long-term pacing support.
Practical Considerations
The electrode is available in various lengths to accommodate different patient anatomies and is compatible with standard pacemaker leads. Proper technique during implantation is crucial to ensure secure attachment and optimal function.
Frequently Asked Questions
What is the implantable endocardial screw-in electrode used for?
It is used for cardiac pacing and sensing in patients with heart rhythm disorders.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to arrhythmias like 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.