Introduction and History
Clinical Evaluation and Performance Testing
Regulatory Requirements
Contemporary Heart Valves
100

Name the two main types of prosthetic heart valves commonly used in medical practice today

What are mechanical valves and bioprosthetic (or tissue) valves?

100

The standards for heart valve substitutes intended for implantation number

What is ISO 5840

100

A replacement heart valve is defined as this class of device.

What is Class III?

100

This powerful imaging technique can affect prosthetic heart valves by inducing heating, displacing metallic components, or causing malfunctions due to strong magnetic fields.

What is MRI?

200

This valve, implanted in 1952, was the first mechanical heart valve designed to address aortic insufficiency.

What is the Hufnagel’s caged-ball valve?

200

A class III device has this unique requirement. 

What is Premarket Approval?

200

Mention one goal about post-approval studies.

Monitor long-term safety and effectiveness--Detect rare or delayed adverse events--Assess specific patient populations--Confirm durability and reliability

300

This heart valve condition occurs when valve leaflets become stiff and thick, restricting proper opening and blood flow.

What is stenosis?

300

This is the ISO number associated with prosthetic heart valves. 

What is ISO5480?
300

Under specific scan conditions, the Edwards SAPIEN 3 Ultra transcatheter heart valves can cause this maximum temperature increase in degrees Celsius after 15 minutes of continuous scanning.

3 Degrees celsius


400

This modern heart valve type aims to combine the durability of mechanical valves with the hemocompatibility of bioprosthetic valves, using advanced materials.

What are polymeric heart valves?

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