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implantable endocardial tined electrode
Telectronics
Summary: The implantable endocardial tined electrode by Telectronics is used for cardiac pacing. Key evidence highlights challenges in lead extraction and infection risks.
FDA Clearance Information
Pathway
510K
Number
K792387 ↗
Decision Date
December 5, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The implantable endocardial tined electrode was cleared by the FDA via the 510(k) pathway on December 5, 1979. It is manufactured by Telectronics and classified as a Class III device.
What It Is
The implantable endocardial tined electrode is a cardiac pacing device designed to improve endocardial fixation through tines. It is intended for use in patients requiring permanent cardiac pacing.
Clinical Applications
This device is commonly used in scenarios requiring long-term cardiac pacing, particularly in patients with bradycardia or heart block. It is implanted endocardially to ensure stable cardiac rhythm management.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, conducted between 1984 and 1997. These studies explore device performance, safety, and extraction challenges.
Reported Outcomes
Published studies report that the tined electrode improves fixation and reduces dislodgment rates. However, there is evidence of increased lead failure and difficulty in extraction, particularly in cases of infection.
Safety Profile
Reported complications include difficulty in extracting chronically implanted leads, increased risk of infection, and lead failure. These issues necessitate careful consideration during implantation and potential reoperation.
Evidence Limitations
The evidence is limited by the age of the studies, with most data collected before 1997. Further research is needed to assess long-term outcomes and advancements in electrode technology.
Frequently Asked Questions
What are the clinical indications for implantable endocardial tined electrode?
The device is indicated for patients requiring permanent cardiac pacing, such as those with bradycardia or heart block.
What outcomes have been reported in clinical studies?
Studies report improved fixation and reduced dislodgment rates, but also highlight challenges with lead extraction and increased failure rates.
What complications have been reported?
Safety data indicate difficulties in lead extraction, increased infection risk, and potential lead failure.
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.