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

During heart valve testing, this property represents the open area of the valve for blood to flow through.

What is the effective orifice area (EOA)?

100

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

What is Class III?

100

This transcatheter heart valve system, made of cow tissue attached to a cobalt-chromium frame, is used to replace failing biological valves without open-heart surgery.

 What is the Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System?

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

The first mitral heart valve replacement (Starr-Edwards) was initially tested on this animal before being used in humans.

What are dogs?

200

A class III device has this unique requirement. 

What is Premarket Approval?

200

Aortic valve stenosis is primarily caused by the buildup of this mineral, which narrows the valve opening and reduces blood flow.

What is calcification?

300

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

What is stenosis?

300

This imaging technique is used to diagnose heart valve complications post implantation.

What is echocardiography?

300

This animal is most typically used to test for heart valve calcification. 

What is a sheep?


300

These studies are conducted after a medical device is approved to monitor long-term safety, detect rare adverse events, and assess specific patient populations.

 What are Post-Approval Studies?

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?

400

The percentage of poly-styrene in Group B testing of the Poli-Valve prototype.

What is 30%?

400

This is the number of cycles that a heart valve must survive in testing.

What is 200 million?

400

Exposure to this medical imaging technology can cause artificial heart valves to move or malfunction, leading to serious complications.

What is MRI?

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