đź“Š Evidence-Based Reference
modified unipolar implant pacing leads w is-1
Medtronic Vascular
Summary: The modified unipolar implant pacing leads w IS-1 by Medtronic Vascular are used for cardiac pacing. Cleared by FDA via 510k in 1990, they are primarily used in scenarios requiring reliable pacing with a focus on unipolar lead advantages. Key evidence highlights the device's efficacy in maintaining pacing thresholds.
FDA Clearance Information
Pathway
510K
Number
K900984 ↗
Decision Date
May 3, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The modified unipolar implant pacing leads w IS-1 were cleared by the FDA through the 510k pathway on May 3, 1990. Manufactured by Medtronic Vascular, this device is classified as Class 3 under product code DTB.
What It Is
The modified unipolar implant pacing leads w IS-1 are designed for cardiac pacing, providing electrical stimulation to maintain heart rhythm. They are intended for use in patients requiring pacing support, leveraging the mechanical integrity of unipolar leads.
Clinical Applications
These pacing leads are commonly used in patients with heart block or other conditions necessitating cardiac pacing. They are particularly useful in scenarios where unipolar leads are preferred due to their mechanical robustness.
Evidence Summary
The literature includes 12 studies ranging from case reports to randomized controlled trials, spanning from 1991 to 2024. These studies explore various aspects of pacing lead performance, including efficacy and safety.
Reported Outcomes
Published studies report that the modified unipolar implant pacing leads w IS-1 maintain effective pacing thresholds. In one study, the unipolar stimulation threshold was found to be 1.6 +/- 0.5 volts. The device has been shown to provide reliable sensing and pacing in both acute and chronic settings.
Safety Profile
Reported complications include issues related to lead integrity and sensing. However, the studies generally indicate a favorable safety profile, with no significant adverse events directly attributed to the device.
Evidence Limitations
The evidence base is limited by the small sample sizes and the variability in study designs. Further research is needed to confirm long-term outcomes and to explore the comparative efficacy of unipolar versus bipolar leads in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for modified unipolar implant pacing leads w IS-1?
The device is indicated for patients requiring cardiac pacing, particularly in cases where unipolar leads are preferred due to their mechanical integrity.
What outcomes have been reported in clinical studies?
Studies report effective pacing thresholds and reliable sensing, with unipolar stimulation thresholds averaging 1.6 +/- 0.5 volts.
What complications have been reported?
Reported complications include issues with lead integrity and sensing, though no significant adverse events have been directly linked to the device.
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.