📋 FDA Reference
Polysafe Implant Pacing Leads W Trabeculok Tip
Cardiac Control Systems
Summary: The Polysafe Implant Pacing Leads are used in cardiac pacing procedures to maintain heart rhythm. They are typically used by cardiologists in hospital settings for patients requiring pacemaker implantation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K883015 ↗
Decision Date ?
October 6, 1988
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Polysafe Implant Pacing Leads were cleared through the FDA 510(k) pathway on October 6, 1988. Manufactured by Cardiac Control Systems, this Class 3 device is essential in cardiac pacing.
What It Is
The Polysafe Implant Pacing Leads are specialized leads used in cardiac pacemaker systems. They are designed to deliver electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. The Trabeculok tip enhances stability and reduces the risk of lead dislodgement, making it a reliable option for long-term pacing.
FDA-Cleared Indications
- Use with a cardiac pacemaker system when permanent cardiac pacing is indicated.
- Provide electrical stimulation to the heart in patients requiring pacing for bradycardia or heart block.
Clinical Applications
- Transvenous implantation of a permanent pacemaker lead in patients with symptomatic slow heart rate.
- Cardiac pacing for patients with atrioventricular or other clinically significant heart block.
- Connection of an implanted pacing lead to a compatible cardiac pacemaker pulse generator.
- Long-term delivery of pacing impulses to the heart after pacemaker implantation.
Practical Considerations
- Lead length and configuration should be selected according to the patient's anatomy and the planned implantation site.
- The lead must be connected to a compatible pacemaker system and implanted using appropriate fluoroscopic and electrophysiology techniques.
- The Trabeculok tip is intended to help maintain lead position; lead placement and testing are still required to confirm stable sensing and pacing thresholds.
- MRI safety cannot be determined from the available FDA record. Patients should not undergo MRI unless the complete implanted system is specifically labeled as MR Safe or MR Conditional under the applicable conditions.
- Potential complications include lead dislodgement, failure to capture or sense, infection, venous injury or thrombosis, perforation, and the need for lead revision or extraction.
Frequently Asked Questions
What is Polysafe Implant Pacing Leads used for?
They are used for cardiac pacing to maintain heart rhythm in patients with conditions like bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac units of hospitals.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to slow heart rate 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.