đź“Š Evidence-Based Reference
Lead Body Changes to Hi Perform Fast-Pass Leads
Pacesetter Systems
Summary: The lead body changes to hi perform fast-pass leads by Pacesetter Systems are used in clinical settings for specific indications. The device was cleared by the FDA via the 510k pathway. Key evidence includes 13 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K861464 ↗
Decision Date ?
May 19, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The device was cleared by the FDA through the 510k pathway on May 19, 1986. It is manufactured by Pacesetter Systems and classified as a Class 3 device.
What It Is
The device involves modifications to the lead body to enhance performance in fast-pass leads. It is intended for use in clinical scenarios requiring precise lead placement and performance.
FDA-Cleared Indications
- The available FDA record identifies the device under product code DTB and does not include detailed indication-for-use wording.
Clinical Applications
- Use as part of a cardiac pacing lead system when consistent with the FDA-cleared labeling.
- Use in cardiac procedures requiring placement of a pacing lead, subject to the specific lead model and instructions for use.
Evidence Summary
The available literature includes 13 studies, though specific details on study types, total sample size, and date range are not provided. The evidence base appears to be diverse, covering various aspects of device performance.
Reported Outcomes
Published studies report limited specific outcomes related to the device. The evidence provided does not detail efficacy findings directly associated with the device's use.
Safety Profile
Reported complications include a lack of specific safety data in the provided evidence. The studies do not detail adverse events directly linked to the device.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the device. Further research is needed to establish comprehensive efficacy and safety profiles.
Practical Considerations
- Confirm the exact lead model, connector type, dimensions, and compatibility with the pulse generator before use.
- Use fluoroscopic or other appropriate imaging guidance and follow the manufacturer’s instructions for positioning and handling.
- MRI safety depends on the complete pacing system, including the lead, generator, and conditions specified in the labeling; do not assume the system is MRI compatible.
- Review patient-specific risks, including infection, bleeding, venous injury, lead dislodgement, cardiac perforation, and abnormal pacing or sensing.
- The available record does not provide lead lengths, diameters, materials, shelf life, or a defined service life.
Frequently Asked Questions
What are the clinical indications for lead body changes to hi perform fast-pass leads?
Refer to FDA documentation for specific clinical indications.
What outcomes have been reported in clinical studies?
The provided evidence does not specify detailed outcomes related to the device.
What complications have been reported?
The evidence does not provide specific safety data or reported complications for the device.
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.