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vascular products implantable pacing
Oscor
Summary: The Oscor vascular products implantable pacing device is used for cardiac pacing. It was FDA cleared via the 510k pathway. Key evidence includes studies on safety and clinical outcomes.
FDA Clearance Information
Pathway
510K
Number
K830950 ↗
Decision Date
April 18, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The device was cleared by the FDA through the 510k pathway on April 18, 1983. It is manufactured by Oscor and classified as a Class III device.
What It Is
This is an implantable pacing device designed for cardiac rhythm management. It is used to provide electrical stimulation to the heart in patients with arrhythmias or conduction disturbances.
Clinical Applications
Commonly used in patients requiring cardiac pacing, such as those with bradycardia or heart block. It is also applicable in scenarios where cardiac resynchronization is needed.
Evidence Summary
The literature includes 13 studies, comprising RCTs, prospective, and retrospective analyses. These studies span from 2024 to 2026, focusing on safety and clinical outcomes.
Reported Outcomes
Published studies report varied outcomes, including the efficacy of leadless pacing and sex-specific responses to cardiac resynchronization therapy. The studies highlight the potential benefits of pacing in improving cardiac function.
Safety Profile
Reported complications include high-grade atrioventricular block post-transcatheter valve replacement and potential lead-related issues. Safety data emphasize the need for careful patient selection and monitoring.
Evidence Limitations
The evidence is limited by underrepresentation of certain populations, such as women, in clinical trials. Further research is needed to establish long-term outcomes and optimize patient selection criteria.
Frequently Asked Questions
What are the clinical indications for vascular products implantable pacing?
The device is indicated for patients with arrhythmias requiring pacing, such as bradycardia or heart block. Refer to FDA documentation for detailed indications.
What outcomes have been reported in clinical studies?
Studies report improved cardiac function with pacing, including leadless and sex-specific responses in cardiac resynchronization therapy.
What complications have been reported?
Safety data indicate risks such as high-grade atrioventricular block and lead-related complications, necessitating careful monitoring.
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.