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s80 implantable cardiac pacing lead
Sorin Biomedica, Fiat, U
Summary: The s80 implantable cardiac pacing lead is used in cardiac pacing procedures to help manage arrhythmias. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K854963 ↗
Decision Date
June 24, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The s80 implantable cardiac pacing lead was cleared by the FDA through the 510(k) pathway on June 24, 1986. It is manufactured by Sorin Biomedica and classified as a Class III device.
What It Is
The s80 implantable cardiac pacing lead is a medical device used in conjunction with pacemakers to deliver electrical impulses to the heart muscle, ensuring proper heart rhythm. It is an endocardial lead, meaning it is placed inside the heart. The lead is designed to be durable and reliable, providing consistent electrical performance over time.
Clinical Applications
This device is commonly used in patients with bradycardia or other arrhythmias that require pacing support. It is typically implanted by cardiologists or electrophysiologists in a hospital setting, often in a cardiac catheterization lab. The patient population includes those with heart block, sick sinus syndrome, or other conditions leading to inadequate heart rate control.
Indications for Use
The s80 lead is indicated for use in patients who require chronic cardiac pacing. This includes individuals with conditions that cause slow heart rhythms or irregular heartbeats that can be managed with a pacemaker.
Practical Considerations
When considering the s80 lead, clinicians should ensure compatibility with the chosen pacemaker device. The lead's design allows for stable placement within the heart, but proper technique during implantation is crucial to avoid dislodgement. Sizing and selection should be based on the patient's specific anatomical and clinical needs.
Related Literature
The linked study compared the electrical performance of three different pacing leads, including the s80, in 99 patients. Key findings showed no significant differences in sensing properties or current flow at threshold among the leads, although the 423S lead had higher impedance. The study provides valuable insights into the performance of different electrode designs, though it is limited by its sample size and the specific leads tested.
Frequently Asked Questions
What is s80 implantable cardiac pacing lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients requiring chronic cardiac pacing due to conditions like slow heart rhythms.
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.