📋 FDA Reference
Pacepath Implant Endocard Pacing Lead
Pacesetter Systems
Summary: The Pacepath Implant Endocard Pacing Lead is a medical device used for cardiac pacing, primarily by cardiologists in hospital settings. It is designed to help manage heart rhythm disorders.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K810286 ↗
Decision Date ?
November 27, 1981
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Pacepath Implant Endocard Pacing Lead was cleared through the FDA 510k pathway on November 27, 1981. Manufactured by Pacesetter Systems, it is classified as a Class 3 device.
What It Is
The Pacepath Implant Endocard Pacing Lead is an implantable device used to deliver electrical impulses to the heart muscle to maintain an adequate heart rate. It is typically used in patients with arrhythmias or heart block. The lead is placed inside the heart via the venous system and connected to a pacemaker, which regulates the heart's electrical activity.
FDA-Cleared Indications
- Cardiac pacing for patients with bradycardia or other rhythm disturbances requiring pacing support.
- Pacing support for patients with heart block or impaired electrical conduction.
- Use with a compatible pacemaker system to deliver electrical impulses to the heart.
Clinical Applications
- Transvenous placement of a pacing lead inside the heart.
- Connection to a pacemaker generator for ongoing cardiac pacing.
- Treatment of bradycardia requiring temporary or long-term pacing support.
- Pacing support for patients with heart block or other clinically significant conduction disorders.
Practical Considerations
- The lead must be matched to a compatible pacemaker generator and connector system.
- Appropriate lead length and configuration should be selected for the patient's anatomy and intended cardiac chamber.
- Placement requires imaging and cardiac electrical testing to confirm the lead position and pacing performance.
- MRI safety is not established from the available record. MRI should be considered only after confirming the complete implanted system's current labeling and conditions.
- Potential complications include bleeding, infection, lead dislodgement, venous injury, cardiac perforation, abnormal heart rhythms, and loss of pacing function.
Frequently Asked Questions
What is the Pacepath Implant Endocard Pacing Lead used for?
It is used for cardiac pacing in patients with rhythm disorders like bradycardia or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions such as bradycardia 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.