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sutureless muocardine pacing leads 471
Intermedics
Summary: The sutureless myocardial pacing leads 471 by Intermedics are used for cardiac pacing without the need for sutures. They are typically used by cardiologists and cardiac surgeons in patients requiring pacing support.
FDA Clearance Information
Pathway
510K
Number
K781570 ↗
Decision Date
February 1, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The sutureless myocardial pacing leads 471 were cleared through the FDA 510k pathway on February 1, 1979. Manufactured by Intermedics, this device is classified as a Class III medical device.
What It Is
The sutureless myocardial pacing leads 471 are designed to provide cardiac pacing by attaching directly to the myocardium without the need for sutures. This device facilitates the delivery of electrical impulses to the heart muscle, helping to maintain an adequate heart rate in patients with bradycardia or other pacing indications. The sutureless design aims to simplify the implantation procedure and reduce operative time.
Clinical Applications
These pacing leads are commonly used in cardiac surgery settings, particularly during procedures where temporary or permanent pacing is required. Cardiologists and cardiac surgeons may use them in patients with heart block, sick sinus syndrome, or other conditions necessitating pacing support. The device is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The device is indicated for patients who require cardiac pacing, such as those with arrhythmias that result in bradycardia. It is particularly useful in situations where a sutureless approach can reduce surgical complexity and time.
Practical Considerations
The leads are typically available in various lengths to accommodate different patient anatomies. Compatibility with existing pacemaker generators should be verified prior to use. Clinicians should be familiar with the sutureless implantation technique to ensure optimal outcomes.
Frequently Asked Questions
What is sutureless myocardial pacing leads 471 used for?
It is used for providing cardiac pacing in patients requiring heart rate support, especially in cases of bradycardia or heart block.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use this device in surgical and interventional settings.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing support, particularly in cases of arrhythmias leading to bradycardia.
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.