The goal of the ACURATE IDE Clinical trial is to evaluate the safety and effectiveness of the ACURATE neo2™ Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
The ACURATE neo2 is the newest valve in the ACURATE Aortic Valve platform, receiving CE Mark in the EU in 2020.
The first generation ACURATE neo received CE Mark in 2014.
Patients included in clinical trials
The ACURATE neo2 Aortic Valve System
The ACURATE neo2™ valve is made up of a stent-like valve frame and animal tissue leaflets. It is placed within the diseased aortic valve to restore proper valve function.
What makes the ACURATE neo2™ valve unique?
It is designed to softly expand and adapt to your valve anatomy, fitting right into your native valve. A special seal outside of the valve is designed to minimize the risk of blood leakage outside the valve frame.
The TAVR Procedure with ACURATE neo2™
During the TAVR procedure, your doctor will use special X-ray equipment to guide the positioning and placement of the new valve. For the most common transfemoral valve replacement, your doctor will make a small incision in your artery at the groin and insert a small, hollow tube catheter.
A special balloon is placed within the aortic valve and then inflated to stretch open your narrowed aortic valve. The balloon is then removed.
The artificial valve is compressed onto a catheter that travels through your body to your heart, inside a large artery that leads to your diseased aortic valve.
Your doctor will expand the valve, pushing the impaired parts of the aortic valve out of the way.
The new valve will begin to function immediately and restore blood flow. Once the valve is in place, your doctor will remove the catheter.