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implantable pacing lead ccs model sv-101
Cardiac Control Systems
Summary: The implantable pacing lead CCS model SV-101 by Cardiac Control Systems is used in cardiac resynchronization therapy (CRT). Key evidence highlights its role in improving clinical status in CRT nonresponders.
FDA Clearance Information
Pathway
510K
Number
K830828 ↗
Decision Date
April 28, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable pacing lead CCS model SV-101 was cleared via the FDA 510(k) pathway on April 28, 1983. It is manufactured by Cardiac Control Systems and classified as a Class 3 device.
What It Is
The implantable pacing lead CCS model SV-101 is designed for use in cardiac resynchronization therapy (CRT), a treatment for heart failure. It functions by delivering electrical impulses to the heart to improve its pumping efficiency.
Clinical Applications
This device is commonly used in patients with heart failure who are nonresponders to standard CRT. It is particularly applicable in scenarios requiring enhanced cardiac synchronization.
Evidence Summary
The available literature includes two peer-reviewed studies, both focusing on cardiac resynchronization therapy. These studies are from 2012 and 2019, encompassing randomized controlled trials and prospective analyses.
Reported Outcomes
Published studies report that the addition of a second left ventricular lead in CRT nonresponders may improve clinical status. The V3 trial suggests potential benefits in triple-site CRT, while the PROSPECT-ECG substudy highlights predictive ECG parameters for CRT outcomes.
Safety Profile
Reported complications include the general risks associated with implantable cardiac devices, though specific adverse events were not detailed in the provided studies. Further research is needed to delineate safety profiles.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety data. Further research is needed to confirm findings and explore long-term outcomes and complications.
Frequently Asked Questions
What are the clinical indications for implantable pacing lead CCS model SV-101?
The device is indicated for use in cardiac resynchronization therapy, particularly in patients who are nonresponders to standard CRT.
What outcomes have been reported in clinical studies?
Studies report improved clinical status in CRT nonresponders with the addition of a second left ventricular lead.
What complications have been reported?
Specific complications were not detailed in the provided studies, indicating a need for further safety data.
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.