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model 430-07 endocardial pacing lead
Intermedics
Summary: The Model 430-07 endocardial pacing lead is a device used for cardiac pacing, typically in patients requiring long-term cardiac rhythm management. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K954610 ↗
Decision Date
December 16, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 430-07 endocardial pacing lead was cleared through the FDA 510(k) pathway on December 16, 1996. It is manufactured by Intermedics and classified as a Class III medical device.
What It Is
The Model 430-07 endocardial pacing lead is a passive-fixation, bipolar, transvenous lead designed for cardiac pacing. It features coradial individually coated conductor coils and a polyurethane insulation sheath, offering a smaller diameter compared to conventional leads. This design facilitates easier implantation and reduces the risk of lead displacement.
Clinical Applications
This device is commonly used in cardiac pacing procedures, particularly in patients with bradycardia or other rhythm disorders requiring pacemaker support. It is typically used in hospital settings by cardiologists and electrophysiologists. The lead's design allows for use in both atrial and ventricular pacing, making it versatile for various patient needs.
Indications for Use
The Model 430-07 is indicated for patients who require cardiac pacing due to conditions like bradycardia or heart block. It is suitable for both atrial and ventricular pacing, providing flexibility in managing different cardiac rhythm disorders.
Practical Considerations
The lead's small diameter (< 5 Fr) makes it comparable to unipolar leads, facilitating easier insertion and reducing patient discomfort. It is compatible with most modern pacemaker devices, but clinicians should verify compatibility with specific pacemaker models before implantation.
Related Literature
The linked study evaluated the safety and efficacy of passive-fixation coradial bipolar endocardial pacing leads, including the Model 430-07. Conducted from 1994 to 1996, it involved 1,068 patients and demonstrated the leads' effectiveness in maintaining cardiac pacing with a low complication rate. However, the study's limitations include its observational nature and the lack of long-term follow-up beyond two years.
Frequently Asked Questions
What is the Model 430-07 endocardial pacing lead used for?
It is used for cardiac pacing in patients with rhythm disorders such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing, suitable for both atrial and ventricular applications.
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.