📊 Evidence-Based Reference
Implantable Cardiac Pacing Leads
Summary: Implantable cardiac pacing leads by Oscor are used for cardiac pacing. Cleared by FDA under 510k pathway. Key evidence highlights successful implantation and safety in short-term follow-up.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K831767 ↗
Decision Date ?
July 26, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The implantable cardiac pacing leads by Oscor were cleared by the FDA via the 510k pathway on July 26, 1983. They are classified as Class 3 devices.
What It Is
Implantable cardiac pacing leads are devices used to deliver electrical impulses to the heart to maintain an adequate heart rate. They are primarily used in patients with arrhythmias to ensure proper cardiac function.
FDA-Cleared Indications
- Use in cardiac pacing systems to deliver electrical stimulation to the heart.
- Use in patients who require pacing to maintain an adequate heart rate.
- Use as part of a pacing system for management of certain cardiac rhythm disorders.
Clinical Applications
- Transvenous implantation of a pacing lead into a heart chamber as part of a permanent pacemaker system.
- Delivery of electrical impulses to the atrium or ventricle in patients requiring bradycardia pacing.
- Use with a cardiac pacing generator to maintain an adequate heart rate.
- Use as a component of a multi-lead pacing system when indicated for cardiac resynchronization therapy.
Evidence Summary
The literature includes 14 studies ranging from 2019 to 2024, encompassing various study types such as RCTs, prospective, and retrospective studies. These studies provide insights into the efficacy and safety of the device.
Reported Outcomes
Published studies report successful implantation of pacing leads with adequate defibrillation testing and good electrical parameters. Short-term follow-up indicates effective pacing with minimal complications, demonstrating the device's efficacy in maintaining cardiac rhythm.
Safety Profile
Reported complications include potential risks associated with implantation, such as lead dislodgement or infection. However, studies indicate that these events are rare and the device is generally well-tolerated.
Evidence Limitations
Current evidence is limited by short-term follow-up and a focus on specific patient populations. Further research is needed to assess long-term outcomes and broader applicability across diverse patient groups.
Practical Considerations
- Lead length, diameter, fixation mechanism and connector type must be matched to the intended heart chamber and compatible pulse generator.
- Implantation generally requires venous access, fluoroscopic imaging and cardiac electrical testing; local anesthesia with procedural sedation or general anesthesia may be used.
- MRI eligibility depends on the specific lead, pulse generator and complete implanted system. Do not assume an individual lead is MRI-safe without checking its labeling and the full system.
- Potential complications include lead dislodgement, failure to capture, abnormal sensing, venous thrombosis, infection, perforation and pneumothorax.
- The device should not be used when the lead or connected pacing system is incompatible, or when infection or another condition makes implantation unsafe.
Frequently Asked Questions
What are the clinical indications for implantable cardiac pacing leads?
Implantable cardiac pacing leads are indicated for patients with arrhythmias requiring cardiac resynchronization or those with bradycardia needing heart rate support.
What outcomes have been reported in clinical studies?
Studies report successful implantation and effective pacing with good electrical parameters and minimal short-term complications.
What complications have been reported?
Reported complications include lead dislodgement and infection, though these are rare and the device is generally well-tolerated.
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.