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model ky pacemaker lead - various
Oscor
Summary: The Model KY Pacemaker Lead by Oscor is a cardiac device used in conjunction with pacemakers for cardiac resynchronization therapy. Key evidence highlights its role in improving outcomes for heart failure patients with wide QRS complex.
FDA Clearance Information
Pathway
510K
Number
K823891 ↗
Decision Date
March 31, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model KY Pacemaker Lead was cleared through the FDA 510(k) pathway on March 31, 1983. It is manufactured by Oscor and classified as a Class III medical device.
What It Is
The Model KY Pacemaker Lead is a cardiac lead designed to be used with pacemakers for cardiac resynchronization therapy (CRT). It helps synchronize the contractions of the heart's ventricles, improving cardiac function in patients with heart failure.
Clinical Applications
This device is commonly used in patients with heart failure who have a wide QRS complex and require cardiac resynchronization therapy. It is particularly relevant in scenarios where improved ventricular synchronization is needed to enhance cardiac output.
Evidence Summary
The available literature includes a mix of study types, such as retrospective cohort studies and registries, with a total of 7 studies identified. The studies span from 2018 to 2020, focusing on the efficacy and safety of cardiac resynchronization therapy.
Reported Outcomes
Published studies report that the use of the Model KY Pacemaker Lead in CRT can improve outcomes in heart failure patients with wide QRS complex. The studies highlight the benefits of continued CRT in patients with Left Ventricular Assist Devices (LVADs) and the advantages of quadripolar leads in providing more programmable pacing options.
Safety Profile
Reported complications include variations in CRT management post-LVAD implantation, with some centers opting to turn off CRT pacing. However, specific adverse events related to the Model KY Pacemaker Lead were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the lack of detailed safety data specific to the Model KY Pacemaker Lead. Further research is needed to explore long-term outcomes and potential complications associated with its use in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for model ky pacemaker lead?
The device is indicated for use in cardiac resynchronization therapy for patients with heart failure and a wide QRS complex.
What outcomes have been reported in clinical studies?
Studies have reported improved outcomes in heart failure patients with wide QRS complex, particularly in those with LVADs.
What complications have been reported?
Safety data from the evidence indicates variations in CRT management post-LVAD implantation, but specific complications related to the device were not detailed.
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.