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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 510K
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.
Clinical Applications
This device is commonly used in endovascular procedures involving aortic aneurysms or dissections. Vascular surgeons and interventional radiologists employ it in hospital settings, particularly in operating rooms or specialized catheterization labs. It is suitable for adult patients requiring aortic repair, especially those with complex vascular anatomies.
Indications for Use
The Talent-Pro Electromagnetic Stimulator is indicated for use in patients requiring aortic-stent-graft placement, typically due to aneurysms or other aortic pathologies. It helps ensure the stent-graft is securely positioned within the aorta.
Practical Considerations
The device is compatible with a range of stent-graft sizes, allowing for flexibility in treating different patient anatomies. Clinicians should be familiar with electromagnetic stimulation techniques and ensure proper calibration for optimal results.
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.