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bipolar sutureless myocardial pacing leads
Possis Medical
Summary: Bipolar sutureless myocardial pacing leads are used for cardiac pacing without sutures. They are primarily used by cardiologists and cardiac surgeons in settings requiring temporary or permanent pacing solutions.
FDA Clearance Information
Pathway
510K
Number
K910528 ↗
Decision Date
August 9, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on August 9, 1991. Manufactured by Possis Medical, it is classified as a Class III device.
What It Is
Bipolar sutureless myocardial pacing leads are designed to provide temporary or permanent cardiac pacing by attaching directly to the myocardium without the need for sutures. These leads use a bipolar configuration to facilitate effective pacing and sensing. They are particularly useful in situations where traditional sutured leads are impractical or pose additional risks.
Clinical Applications
These leads are commonly used in cardiac surgery, particularly in patients undergoing procedures that may require temporary pacing post-operatively. They are also used in patients with bradyarrhythmias or heart block who need a permanent pacing solution. The device is typically employed in hospital settings, particularly in cardiac surgery and cardiology departments.
Indications for Use
The device is indicated for patients requiring myocardial pacing, particularly those undergoing cardiac surgery or with conditions like bradycardia or heart block. It is suitable for both temporary and permanent pacing needs.
Practical Considerations
The leads are designed for easy attachment to the heart without sutures, reducing operative time and potential complications. They are compatible with standard pacing generators. Clinicians should be aware of the specific technique for placing these leads to ensure optimal performance.
Related Literature
The linked study examined the outcomes of 200 patients who received epicardial pacing via sutureless myocardial electrodes. The study reported a low intraoperative mortality rate of 0.5% and a 30-day perioperative mortality rate of 2.0%. Postoperative complications included postpericardiotomy syndrome and pneumonia. The study highlights the effectiveness and safety of this approach, though it is limited by its age and the specific patient population studied.
Frequently Asked Questions
What is bipolar sutureless myocardial pacing leads used for?
They are used for providing cardiac pacing without sutures, particularly in cardiac surgery or for patients with bradyarrhythmias.
What specialties typically use this device?
Cardiology and cardiac surgery specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for myocardial pacing in patients undergoing cardiac surgery or with conditions like bradycardia or heart block.
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.