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permanent pacing lead model rxbj series
Oscor Medical
Summary: The permanent pacing lead model RXBJ series by Oscor Medical is used for cardiac pacing. It is FDA 510k cleared and linked to 10 studies. Key findings include its use in various pacing techniques.
FDA Clearance Information
Pathway
510K
Number
K882462 ↗
Decision Date
October 28, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The permanent pacing lead model RXBJ series was cleared through the FDA 510k pathway on October 28, 1988. Manufactured by Oscor Medical, it is classified as a Class 3 device.
What It Is
The permanent pacing lead model RXBJ series is designed for cardiac pacing, providing electrical stimulation to maintain heart rhythm. It is used in conjunction with pacemakers for patients with arrhythmias.
Clinical Applications
Commonly used in scenarios requiring cardiac pacing, such as atrioventricular block and sick sinus syndrome. It is suitable for both adult and pediatric populations, adapting to various anatomical and clinical needs.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, published between 2015 and 2023. These studies explore different pacing techniques and patient outcomes.
Reported Outcomes
Published studies report that the RXBJ series leads are effective in maintaining cardiac rhythm in patients with arrhythmias. They have been used successfully in both adult and pediatric populations, with outcomes showing improved heart function and patient quality of life.
Safety Profile
Reported complications include potential lead dislodgement and infection at the implantation site. Some studies noted challenges in lead placement, particularly in pediatric patients due to anatomical considerations.
Evidence Limitations
Evidence gaps include a lack of long-term outcome data and limited studies on specific patient subgroups. Further research is needed to explore the device's performance in diverse clinical settings and its long-term safety profile.
Frequently Asked Questions
What are the clinical indications for permanent pacing lead model RXBJ series?
The device is indicated for use in patients requiring cardiac pacing due to arrhythmias such as atrioventricular block and sick sinus syndrome.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of cardiac rhythm and improved heart function in both adult and pediatric patients.
What complications have been reported?
Safety data indicates potential complications such as lead dislodgement and infection at the implantation site.
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.