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endocardial screw-in lead with platinum porous tip
Diag
Summary: The endocardial screw-in lead with a platinum porous tip is used for cardiac pacing and sensing. It is primarily utilized by cardiologists in electrophysiology settings.
FDA Clearance Information
Pathway
510K
Number
K852446 ↗
Decision Date
September 17, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on September 17, 1985. It is manufactured by Diag and is classified as a Class III device.
What It Is
The endocardial screw-in lead is a component of cardiac pacing systems, designed to be implanted in the heart's endocardium. It features a platinum porous tip that facilitates stable electrical conduction for effective pacing and sensing. This device is typically used in patients requiring long-term cardiac rhythm management.
Clinical Applications
This lead is commonly used in cardiac electrophysiology, particularly for patients with arrhythmias requiring pacemaker implantation. It is suitable for both atrial and ventricular applications, and is often used in hospital settings by cardiologists and electrophysiologists. The device is indicated for patients who need reliable pacing and sensing capabilities.
Indications for Use
The FDA indications suggest this device is for patients needing cardiac pacing and sensing, often due to arrhythmias or heart block. It is suitable for those requiring a permanent pacemaker lead.
Practical Considerations
The lead is typically available in various lengths to accommodate different patient anatomies. It is compatible with most modern pacemaker generators. Proper technique during implantation is crucial to ensure optimal lead positioning and function.
Related Literature
The linked study evaluated the performance of a similar bipolar active fixation lead in the atrial position. It found that after the mannitol helix dissolved, the lead provided stable sensing and pacing. The study involved 73 leads implanted in 28 patients, with follow-up showing satisfactory long-term performance. However, the study's interim nature and limited sample size are notable limitations.
Frequently Asked Questions
What is the endocardial screw-in lead used for?
It is used for cardiac pacing and sensing in patients with arrhythmias or heart block.
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 patients needing cardiac pacing and sensing, often due to arrhythmias 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.