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type yr endocardial lead
Biotronik Sales
Summary: The Type YR Endocardial Lead is a cardiac device used in pacemaker systems to ensure proper heart rhythm management. It is primarily used by cardiologists and electrophysiologists in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K810492 ↗
Decision Date
March 20, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Type YR Endocardial Lead by Biotronik Sales was cleared via the FDA 510(k) pathway on March 20, 1981. It is classified as a Class III device under product code DTB.
What It Is
The Type YR Endocardial Lead is a specialized lead used in pacemaker systems to deliver electrical impulses to the heart. It is designed to be placed endocardially, meaning it is positioned inside the heart chambers. The lead helps in maintaining adequate heart rhythm by transmitting signals from the pacemaker to the heart muscle, ensuring effective cardiac pacing.
Clinical Applications
This device is commonly used in cardiac electrophysiology and cardiology settings, particularly for patients with arrhythmias requiring pacemaker support. It is typically used in hospital settings during pacemaker implantation procedures. The device is suitable for a wide range of patients, including those with bradycardia or other rhythm disorders that necessitate pacing.
Indications for Use
The Type YR Endocardial Lead is indicated for patients who require a pacemaker to manage heart rhythm disorders. It is particularly useful in conditions where the heart's natural pacemaker is not functioning properly, leading to slow heart rates or irregular rhythms.
Practical Considerations
When considering this device, clinicians should ensure compatibility with the pacemaker system being used. The lead's design may include features like screw-in mechanisms for stable placement. Proper sizing and placement technique are crucial to minimize complications such as lead dislodgement.
Related Literature
The linked study examined the performance of special-type pacemaker leads, including the Type YR Endocardial Lead. It found that while special-type electrodes could reduce dislodgement rates, some models had higher complication rates. The study highlighted the importance of lead design in minimizing complications, but also noted limitations in sample size and variability in lead performance.
Frequently Asked Questions
What is the Type YR Endocardial Lead used for?
It is used in pacemaker systems to manage heart rhythm disorders by delivering electrical impulses to the heart.
What specialties typically use this device?
Cardiology and electrophysiology specialists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring pacemaker support due to heart rhythm disorders 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.