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intermedics model 430-07 bipolar implantable endocardial pacing lead
Intermedics
Summary: The Intermedics Model 430-07 is a bipolar implantable endocardial pacing lead used in cardiac pacing. It is utilized by cardiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K954719 ↗
Decision Date
February 27, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics Model 430-07 received FDA clearance via the 510k pathway on February 27, 1996. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Intermedics Model 430-07 is a bipolar endocardial pacing lead designed for implantation in the heart to deliver electrical impulses for cardiac pacing. It features a passive-fixation mechanism and is constructed with coradial individually coated conductor coils and a polyurethane insulation sheath. This design allows for reliable electrical conduction and mechanical stability within the cardiac environment.
Clinical Applications
This device is commonly used in cardiac pacing procedures, particularly in patients with bradycardia or other rhythm disorders requiring electrical stimulation of the heart. It is typically utilized in settings such as hospitals and specialized cardiac care centers, and is implanted by cardiologists or electrophysiologists. The device is suitable for both atrial and ventricular pacing, accommodating a wide range of patient needs.
Indications for Use
The FDA indications suggest that this device is intended for patients who require assistance in maintaining an adequate heart rate due to conditions like bradycardia. It is suitable for individuals who need long-term cardiac pacing support.
Practical Considerations
The Model 430-07 is designed to be compatible with a variety of pacemaker generators. Its small diameter (< 5 Fr) makes it less invasive compared to conventional leads, potentially reducing patient discomfort and facilitating easier implantation. Clinicians should ensure proper lead positioning and fixation during the procedure.
Related Literature
A study conducted by ThinLine Clinical Investigators evaluated the safety and efficacy of similar bipolar, passive-fixation pacing leads. The study involved 1,536 leads implanted in 1,068 patients across multiple centers. It demonstrated the leads' effectiveness and safety over follow-up periods up to 24 months. However, the study was limited by its observational nature and the lack of a control group.
Frequently Asked Questions
What is the Intermedics Model 430-07 used for?
It is used for cardiac pacing in patients with rhythm disorders such as bradycardia, providing electrical impulses to maintain a regular heart rate.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like bradycardia, to help maintain adequate heart rate and rhythm.
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.