📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Myocardial pacing in patients who require permanent or temporary cardiac pacing.
- Use as a unipolar myocardial lead connected to a compatible cardiac pacemaker system.
Clinical Applications
- Myocardial lead placement during pacemaker implantation.
- Pacing support for patients with bradycardia or heart block when a myocardial lead is selected.
- Use during cardiac surgery when the lead is attached directly to the epicardial surface of the heart.
- Connection to a compatible pacemaker generator for delivery of pacing impulses.
Practical Considerations
- The lead is intended for myocardial attachment without sutures; implantation requires training in the specific attachment technique.
- Confirm electrical and mechanical compatibility with the pacemaker generator and any extension or connector used.
- The FDA record provided does not specify lead lengths, electrode dimensions, or a complete size range; consult the original labeling and device documentation.
- MRI safety is not established by the information provided. Do not assume the lead or the complete implanted pacing system is MRI-conditional.
- Potential contraindications and warnings include unsuitable myocardial tissue, infection at the implantation site, poor lead performance, and incompatibility with the connected pacing system.
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.