📋 FDA Reference
Cordis Hi-Flex Pervenous Bipolar Lead
Summary: The Cordis Hi-Flex Pervenous Bipolar Lead is a medical device used in cardiac pacing. It is primarily utilized by cardiologists for patients requiring pacemaker therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K860846 ↗
Decision Date ?
June 26, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Cordis Hi-Flex Pervenous Bipolar Lead was cleared via the FDA 510k pathway on June 26, 1986. It is manufactured by Cordis and classified as a Class 3 device.
What It Is
The Cordis Hi-Flex Pervenous Bipolar Lead is a specialized lead used in cardiac pacing systems. It functions by transmitting electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. The bipolar design allows for more precise sensing and pacing, which is critical for effective cardiac therapy.
FDA-Cleared Indications
- Use as a transvenous bipolar lead in a cardiac pacing system.
- Deliver pacing impulses from an implanted pacemaker to the heart and sense cardiac electrical activity.
- Use in patients for whom permanent cardiac pacing is indicated, according to the labeling for the compatible pacemaker system.
Clinical Applications
- Transvenous implantation as part of a permanent pacemaker system.
- Cardiac pacing for patients with clinically indicated slow heart rates or other rhythm disorders requiring pacing.
- Bipolar sensing and pacing during pacemaker therapy.
- Placement through the venous system into a cardiac chamber selected by the treating electrophysiology team.
Practical Considerations
- The lead is available in different lengths; the appropriate length depends on venous access, cardiac anatomy and the planned pacemaker configuration.
- Compatibility must be confirmed with the pacemaker generator and connector system before implantation.
- Placement generally requires venous access and fluoroscopic guidance, with local anesthesia and sedation or other anesthesia according to the procedure.
- The record provided does not establish MRI compatibility. MRI should be avoided unless the complete pacemaker system is specifically documented as MRI-conditional and the applicable conditions are met.
- Potential complications include lead dislodgement, failure to capture or sense, venous injury or thrombosis, infection, arrhythmia and cardiac perforation.
Frequently Asked Questions
What is the Cordis Hi-Flex Pervenous Bipolar Lead used for?
It is used for cardiac pacing in patients with arrhythmias or bradycardia, helping to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device, particularly in hospital cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing, such as those with slow heart rates or irregular 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.