đź“‹ FDA Reference
Talent-Pro Electromagnetic Stimulator
Remed
Summary: The Talent-Pro Electromagnetic Stimulator by Remed is a Class 2 medical device used in the management of aortic-stent-grafts. It is typically used by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K202031 ↗
Decision Date ?
May 6, 2021
Product Code ?
IPF
Device Class ?
Class 2
Evidence ?
0 studies
The Talent-Pro Electromagnetic Stimulator was cleared through the FDA 510k pathway on May 6, 2021. Manufactured by Remed, it is classified as a Class 2 device under product code IPF.
What It Is
The Talent-Pro Electromagnetic Stimulator is a medical device designed to assist in the placement and stabilization of aortic-stent-grafts. It uses electromagnetic stimulation to ensure precise deployment and adherence of the stent-graft to the aortic wall. This technology is particularly useful in minimally invasive vascular procedures, providing enhanced control and accuracy.
FDA-Cleared Indications
- Use during placement of aortic stent-grafts.
- Use to assist with positioning and stabilization of an aortic stent-graft within the aorta.
Clinical Applications
- Support for endovascular aortic stent-graft placement.
- Assistance with positioning an aortic stent-graft during minimally invasive aortic repair.
- Assistance with stabilization and adherence of an aortic stent-graft to the aortic wall.
Practical Considerations
- Use should follow the device labeling, manufacturer instructions, and the compatibility requirements of the selected aortic stent-graft.
- The system requires appropriate setup and calibration by trained operating-room or catheterization-laboratory personnel.
- The device is used with fluoroscopic and other procedural imaging; it does not replace imaging confirmation of stent-graft position, seal, or patency.
- The supplied FDA record does not establish MRI safety, MRI conditional status, or compatibility with specific MRI environments. Confirm current labeling before MRI exposure.
- Patient selection, contraindications, and precautions depend on the associated stent-graft system and the planned aortic procedure.
Frequently Asked Questions
What is Talent-Pro Electromagnetic Stimulator used for?
It is used for the precise placement and stabilization of aortic-stent-grafts in vascular procedures.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in patients requiring aortic-stent-graft placement, particularly for aortic aneurysms or dissections.
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.