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Polysafe Implant Pacing Leads W Tined Fixa Tip
Cardiac Control Systems
Summary: The Polysafe Implant Pacing Leads with Tined Fixa Tip are used in cardiac pacing procedures to ensure stable lead placement in the heart. They are primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K883016 ↗
Decision Date ?
September 16, 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 September 16, 1988, by Cardiac Control Systems. This device is classified as Class III under the product code DTB.
What It Is
The Polysafe Implant Pacing Leads with Tined Fixa Tip are medical devices used in cardiac pacing. These leads are designed to be implanted in the heart to deliver electrical impulses that regulate heartbeats. The tined fixa tip helps secure the lead in place, reducing the risk of dislodgement. This is crucial for patients requiring consistent cardiac pacing.
FDA-Cleared Indications
- Use with an implanted cardiac pacemaker when a pacing lead is needed to deliver electrical stimulation to the heart.
- Use in patients requiring cardiac pacing for clinically significant slow heart rates or conduction disorders, including heart block, when prescribed by a qualified physician.
Clinical Applications
- Implantation as part of a permanent pacemaker system.
- Delivery of pacing impulses to the heart in patients who require long-term cardiac rhythm support.
- Use during transvenous pacemaker lead placement when the lead must be positioned and secured within a cardiac chamber.
Practical Considerations
- Available lead lengths and configurations should be selected for the patient's anatomy and the intended cardiac chamber.
- The lead must be connected to a compatible pacemaker generator and tested for sensing, pacing threshold, and lead impedance during implantation.
- The tined fixation feature is intended to help stabilize the lead, but careful positioning and follow-up are still required because lead dislodgement, fracture, insulation damage, or loss of function can occur.
- MRI safety cannot be determined from the available record. Patients and clinicians should verify the complete implanted system's current MRI labeling before an MRI examination.
- Implantation should be performed by clinicians trained in pacemaker procedures, using appropriate imaging, sterile technique, and manufacturer instructions.
Frequently Asked Questions
What is Polysafe Implant Pacing Leads used for?
They are used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The leads are indicated for patients needing cardiac pacing due to conditions like 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.