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Medical Specialties > Structural Heart > ACURATE IDE Trial > Severe Aortic Stenosis & TAVR

Boston Scientific is no longer seeking regulatory approval of ACURATE neo2™ or ACURATE Prime™ in the United States or other countries.  This decision was made due to the increased clinical and regulatory requirements to maintain regulatory approvals in global markets and to obtain approvals in new regions.  

Patients who have been treated with an ACURATE neo2 valve or ACURATE Prime XL valve as part of the ACURATE IDE clinical trial should continue with their study follow-up care.  

If you are an ACURATE IDE patient with an ACURATE valve and have specific questions about your clinical care, please discuss with your study doctor. 

What is Severe Aortic Valve Stenosis?

Severe aortic valve stenosis is the significant narrowing of the aortic valve opening. Over time, the valve leaflets can become stiff, reducing their ability to fully open and close, thus restricting blood flow out of the heart. When this happens, your heart must work harder to move blood throughout the body. This additional workload may eventually overwhelm the heart and cause it to fail.

Download the Guide Here
 
Healthy and Diseased Valves
 

The symptoms most frequently associated with severe aortic valve stenosis include:

Shortness of breath

Fatigue

Difficulty when exercising or completing
day-to-day activities

Chest pain, pressure, or tightness

Feeling lightheaded or dizzy

The only effective treatment for severe aortic valve stenosis is to replace the aortic valve. If the diseased valve is not replaced, your symptoms will probably worsen to heart failure and possibly even death.

 
 

What Is Transcatheter Aortic Valve Replacement?

Transcatheter aortic valve replacement (TAVR) is a nonsurgical procedure to replace the aortic valve without open-heart surgery. To access your heart, your doctor will make a small incision in your artery and insert a small, hollow tube.

Although the femoral artery in your groin is often chosen, there are arteries in the chest and neck that lead to the heart as well.

Transfemoral TAVI procedure
 
Next: The ACURATE™ Aortic Valve Platform
 
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