TAVR – Next Generation Expansion Valve

Edwards Lifesciences has announced that the next generation balloon-expandable valve has received FDA approval. He will come to replace the transcatheter aortic valve. Designed for patients with severe symptomatic aortic stenosis with intermediate or greater risk. Is established through open-heart surgery.

As previously reported in Cardiology Today Intervention, a new-generation balloon valve (Sapien 3 Ultra) had previously received permission to be used in Europe in November.

“The Sapien 3 Ultra advanced system includes an artificial valve and a new implementation system to meet the needs of both patients and doctors. Based on our best-in-class Sapien 3 performance to further improve and improve patient care, ”said Larry L. Wood, corporate vice president of transcatheter heart valves, in a press release. “We look forward to the introduction of the Sapien 3 Ultra system for patients in the United States.”

Edwards Lifesciences announced that the next generation balloon-expandable valve has received FDA approval to replace the transcatheter aortic valve in patients with severe symptomatic aortic stenosis with intermediate or greater risk for open-heart surgery.

“The Edwards Sapien 3 Ultra system provides significant technological advances that help further optimize the transcatheter aortic valve replacement procedure, adding simplicity and improving patient care,” says John G. Webb, MD, director of interventional cardiology and heart catheterization laboratories at Saints Hospital Paul in Vancouver and professor of cardiology at the University of British Columbia.

The new valve, expandable balloon, is excellent and looks more user-friendly than the previous version. Now it will be possible to choose specific TAVR valves for individual characteristics of specific patients. Edwards valves are often used in cases with basic conduction disorders, such as the bifassicular block, because balloon-expandable valves have a lower speed AV unit of a high degree compared to self-expanding valves (Corevalve, Medtronic product family) or mechanically expanding valves (Lotus, Boston Scientific).

In a separate case with significant nodal calcium in the outflow tract, if a valve expanded with a balloon were used, one could push the calcium nodule through the outflow tract. Lotus Edge is used for this case because of its gradual expansion with high radial strength, excellent sealing properties. This reduces the likelihood of valve leakage and increases the possibility of re-positioning, which allows you to ideally place the valve without breaking the annular or conductive path.

Video: Transcatheter Aortic Valve Implantation (TAVI)