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products implant pacing lead tined modification
Oscor Medical
Summary: The implant pacing lead tined modification by Oscor Medical is used for cardiac pacing. Key evidence highlights its high-impedance pacing capability and favorable implantation data.
FDA Clearance Information
Pathway
510K
Number
K913201 ↗
Decision Date
September 23, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on September 23, 1991. It is manufactured by Oscor Medical and classified as a Class 3 device.
What It Is
The implant pacing lead tined modification is a cardiac device designed for pacing. It features a tined design to secure placement and is intended for use in patients requiring cardiac pacing.
Clinical Applications
This device is commonly used in scenarios requiring reliable cardiac pacing, particularly in patients with arrhythmias or heart block. It is designed to improve pacing thresholds and reduce complications.
Evidence Summary
The literature includes two studies, one from 1999 and another from 2004. These studies encompass various designs, including prospective and retrospective analyses, focusing on the device's efficacy and safety.
Reported Outcomes
Published studies report that the implant pacing lead demonstrates favorable pacing thresholds at implantation, with a median threshold of 0.6 V. This is considered better than most published data on other atrial leads.
Safety Profile
Reported complications include lead dislodgment and diaphragmatic pacing, which occasionally necessitate reoperation or electrical abandonment. These issues are consistent with typical risks associated with pacing leads.
Evidence Limitations
The evidence is limited by the small number of studies and lack of comprehensive safety data. Further research is needed to establish long-term outcomes and safety profiles for diverse patient populations.
Frequently Asked Questions
What are the clinical indications for implant pacing lead tined modification?
The device is indicated for patients requiring cardiac pacing, particularly those with arrhythmias or heart block.
What outcomes have been reported in clinical studies?
Studies report favorable pacing thresholds at implantation, with a median threshold of 0.6 V, outperforming many other atrial leads.
What complications have been reported?
Safety data indicate complications such as lead dislodgment and diaphragmatic pacing, which may require reoperation.
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.