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endocardial pacing electrode
Coratomic
Summary: The endocardial pacing electrode by Coratomic is a device used for cardiac pacing. It is primarily used in patients requiring cardiac resynchronization therapy. Key evidence highlights its use in patients with heart failure who are ineligible for conventional CRT.
FDA Clearance Information
Pathway
510K
Number
K772309 ↗
Decision Date
February 6, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The endocardial pacing electrode by Coratomic was cleared by the FDA via the 510k pathway on February 6, 1978. It is classified as a Class 3 medical device.
What It Is
The endocardial pacing electrode is a device designed for cardiac pacing, particularly in patients who require cardiac resynchronization therapy. It functions by delivering electrical impulses to the heart muscle to maintain an adequate heart rate.
Clinical Applications
This device is commonly used in clinical scenarios where patients have heart failure and are ineligible for conventional cardiac resynchronization therapy due to anatomical constraints. It offers an alternative for patients who cannot undergo traditional lead implantation.
Evidence Summary
The available literature includes 15 studies, ranging from case series to randomized controlled trials, conducted between 1979 and 2025. These studies explore the feasibility, safety, and efficacy of the device in various clinical settings.
Reported Outcomes
Published studies report that the endocardial pacing electrode is effective in providing cardiac resynchronization in patients with heart failure who are not candidates for conventional CRT. The SELECT-LV study highlighted its potential to improve outcomes in 30% to 40% of patients who do not respond to traditional CRT.
Safety Profile
Reported complications include diaphragmatic twitching and pericardial effusion, as noted in a 1995 study. These adverse events are associated with the implantation and positioning of the pacing electrode.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to establish long-term outcomes and to compare the device's efficacy with other pacing systems.
Frequently Asked Questions
What are the clinical indications for endocardial pacing electrode?
The device is indicated for patients requiring cardiac resynchronization therapy, particularly those who cannot undergo conventional lead implantation due to anatomical constraints.
What outcomes have been reported in clinical studies?
Studies report improved cardiac resynchronization in patients with heart failure, with the SELECT-LV study showing benefits in 30% to 40% of patients who do not respond to traditional CRT.
What complications have been reported?
Safety data indicate complications such as diaphragmatic twitching and pericardial effusion, related to the implantation and positioning of the electrode.
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.