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100 Cm Permanent Pacing Lead Models
Telectronics Pacing Systems
Summary: The 100 cm permanent pacing lead models by Telectronics Pacing Systems are used in cardiac pacing. Cleared by FDA via 510k in 1991, they are primarily used for managing bradyarrhythmias. Key evidence highlights their role in maintaining cardiac rhythm.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K911273 ↗
Decision Date ?
August 28, 1991
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The device was cleared by the FDA through the 510k pathway on August 28, 1991. It is manufactured by Telectronics Pacing Systems and classified as a Class 3 device.
What It Is
The 100 cm permanent pacing lead models are designed for cardiac pacing, providing electrical stimulation to the heart to maintain an adequate heart rate. They are intended for patients with bradyarrhythmias requiring permanent pacing.
FDA-Cleared Indications
- Permanent cardiac pacing in patients with symptomatic bradyarrhythmias.
- Permanent cardiac pacing in patients with cardiac conduction system disorders requiring pacemaker therapy.
Clinical Applications
- Connection between an implanted pacemaker generator and the heart.
- Delivery of electrical stimulation to maintain an adequate heart rate.
- Use during permanent pacemaker implantation for appropriate bradyarrhythmias.
- Pacing support for patients with conduction disorders requiring long-term cardiac rhythm management.
Evidence Summary
The available literature includes a mix of RCTs, prospective, retrospective studies, and case series, with a total of 10 studies reviewed. The studies span from 2000 to 2023, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the use of permanent pacing leads is effective in maintaining cardiac rhythm and improving symptoms in patients with bradyarrhythmias. Outcomes indicate improved left ventricular ejection fraction and reduced incidence of heart failure symptoms. The device is also associated with successful pacing in cases of superior vena cava obstruction.
Safety Profile
Reported complications include potential conduction disturbances such as left bundle branch block and high-degree atrioventricular block following device implantation. Historical concerns about MRI compatibility have been addressed in more recent studies.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some studies. Further research is needed to explore long-term outcomes and the impact of newer pacing technologies on patient quality of life.
Practical Considerations
- The lead length is 100 cm; adequate length must be confirmed for the selected venous access route, heart chamber, and pacemaker generator.
- Compatibility with the pacemaker generator, connector standard, lead diameter, and implantation tools must be verified before use.
- Implantation generally requires venous access and fluoroscopic or other imaging guidance, with lead positioning in the appropriate cardiac chamber.
- MRI safety is model-specific. Do not assume the lead is MRI-conditional; review the original labeling and the complete implanted system before MRI.
- Potential complications include infection, bleeding, venous injury or thrombosis, lead dislodgement, fracture, insulation failure, loss of capture, and cardiac perforation.
Frequently Asked Questions
What are the clinical indications for 100 cm permanent pacing lead models?
The device is indicated for patients with bradyarrhythmias requiring permanent pacing, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report improved cardiac rhythm management and symptom relief in patients with bradyarrhythmias, with some evidence of improved left ventricular function.
What complications have been reported?
Safety data indicate potential conduction disturbances such as left bundle branch block and high-degree atrioventricular block post-implantation.
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.