📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Chronic cardiac pacing for patients who require pacemaker support.
- Pacing treatment for slow heart rhythms, including bradycardia.
- Pacing for rhythm disorders associated with heart block, sick sinus syndrome, or similar conditions requiring cardiac pacing.
Clinical Applications
- Implantation with a compatible pacemaker system for chronic cardiac pacing.
- Endocardial placement in the heart to deliver pacing impulses.
- Treatment of bradycardia requiring permanent pacing.
- Pacing support for selected patients with heart block or sick sinus syndrome.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator and the intended pacing configuration.
- Implantation requires imaging and electrical testing to confirm appropriate position, sensing, and pacing thresholds.
- Lead selection and placement depend on the patient's cardiac anatomy, venous access, clinical indication, and required pacing location.
- Secure fixation and careful handling are important to reduce the risk of lead dislodgement, fracture, or insulation damage.
- MRI safety cannot be determined from this historical device record alone; the complete lead-generator system and current manufacturer labeling must be verified before MRI.
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.