đź“‹ FDA Reference
myopore tm unipolar sutureless myocardial leads
Possis Medical
Summary: The myopore tm unipolar sutureless myocardial leads are used for cardiac pacing. They are primarily utilized by cardiologists in settings requiring myocardial lead placement without sutures.
FDA Clearance Information
Pathway
510K
Number
K885175 ↗
Decision Date
July 14, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The myopore tm unipolar sutureless myocardial leads were cleared through the FDA 510(k) pathway on July 14, 1989. Manufactured by Possis Medical, this Class 3 device is designed for cardiac applications.
What It Is
The myopore tm unipolar sutureless myocardial leads are specialized cardiac leads designed to be attached to the heart muscle without the need for sutures. These leads facilitate electrical conduction to support cardiac pacing, which is crucial for patients with arrhythmias or heart block. The sutureless design simplifies the implantation process and reduces surgical time.
Clinical Applications
These myocardial leads are commonly used in cardiac surgery and electrophysiology procedures, particularly in patients requiring pacemaker implantation. Cardiologists and cardiac surgeons in hospital settings typically use these leads for patients with bradycardia or heart block. The device is suitable for both adult and pediatric populations needing reliable pacing solutions.
Indications for Use
The device is indicated for patients who require myocardial pacing due to conditions like heart block or bradycardia. It is particularly beneficial for those who need a less invasive lead attachment method.
Practical Considerations
The sutureless design of the leads allows for quicker implantation and potentially less trauma to the myocardial tissue. Compatibility with existing pacemaker systems should be verified, and clinicians should be trained in the specific technique for attaching these leads.
Frequently Asked Questions
What is myopore tm unipolar sutureless myocardial leads used for?
It is used for myocardial pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for myocardial pacing in patients with conditions like heart block or 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.