LOTUS Edge™ Aortic Valve System
How Transcatheter Aortic Valve Replacement Works
Treat Your Heart. Protect Your Brain.
After Your Procedure
Resources and Support
Severe aortic stenosis and the valve replacement procedure: A guide for patients and their families.
An estimated 1.5 million people in the U.S. suffer from aortic stenosis.1 Learn more about treatment options.
Cerebral Embolic Protection with the SENTINEL™ Cerebral Protection System: A guide for patients and their families.
Why is Protected TAVR important? Learn more.
Transcatheter Heart Valve Replacement (TAVR) with the LOTUS Edge™ Aortic Valve System
This guide will help you understand more about the procedure and the benefits of using the LOTUS Edge Aortic Valve System.
Risks are associated with all medical implantation procedures. The risks include but are not limited to:
- Access site complications, typically in the groin, including arteriovenous fistula, hematoma or lymphatic problems
- Allergic reaction to device or procedural materials
- Arrhythmia, abnormal heart beats, or new conduction system injury including need for permanent pacemaker
- Heart attack or heart failure
- Stroke, transient ischemic attack (TIA), cerebral infarction or neurologic deficits
- Death
- Clotting in the blood stream or thrombosis (including air, tissue, thrombus or device fragments)
- Heart tissue or valvular injury
- Permanent disability
- Fluid in the space that surrounds the lungs or heart
- Kidney failure or damage
- Difficulty breathing
- Damage to the artificial valve causing stenosis or regurgitation
These complications may require additional medical, percutaneous or surgical intervention, including re-operation and replacement of the valve. These complications may be very serious and possibly fatal. Be sure to talk with your doctor so that you thoroughly understand all the risks and benefits associated with the implantation of the LOTUS Edge Aortic Valve Device.