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intermedics poly flex epicardial suture
Intermedics
Summary: The Intermedics Poly Flex Epicardial Suture is a medical device used in cardiac surgery to secure epicardial leads. It is primarily used by cardiothoracic surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K812221 ↗
Decision Date
October 6, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics Poly Flex Epicardial Suture was cleared through the FDA 510(k) pathway on October 6, 1981. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Intermedics Poly Flex Epicardial Suture is designed for use in cardiac surgeries, specifically for securing epicardial leads to the heart tissue. It is made of materials that are compatible with cardiac tissue and designed to minimize tissue reaction. This device is crucial in ensuring the stability and functionality of epicardial leads, which are used for pacing or monitoring cardiac activity.
Clinical Applications
This device is commonly used in procedures involving the implantation of epicardial pacemaker leads, particularly in patients where transvenous lead placement is not feasible. It is utilized in cardiothoracic surgery, often in pediatric and adult patients with congenital heart defects or in those undergoing cardiac resynchronization therapy. The device is typically used in operating rooms within hospital settings.
Indications for Use
The FDA indications suggest that this device is intended for patients requiring epicardial lead placement, often due to anatomical challenges or specific cardiac conditions. It is suitable for use in both adult and pediatric populations needing cardiac pacing or monitoring.
Practical Considerations
The Intermedics Poly Flex Epicardial Suture comes in various sizes to accommodate different patient anatomies. It is important to ensure compatibility with the specific epicardial leads being used. Surgeons should be familiar with the suture technique to ensure secure placement and minimize complications.
Frequently Asked Questions
What is the Intermedics Poly Flex Epicardial Suture used for?
It is used to secure epicardial leads to the heart tissue during cardiac surgeries.
What specialties typically use this device?
Cardiothoracic surgeons primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for securing epicardial leads in patients requiring cardiac pacing or 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.