On Aug. 5, 2020, physicians at the Texas Cardiac Arrhythmia Institute( TCAI) at St. David's Medical Center in Austin, Texas, and Los Robles Health System in Thousand Oaks, California, became the first in the nation to implant the only FDA-approved device for the reduction of stroke risk in patients with non-valvular atrial fibrillation (A Fib). The physicians at these hospitals, both HCA Healthcare facilities, performed near simultaneous implantation of the WATCHMAN FLXTM Left Atrial Appendage Closure (LAAC).
it is very exciting. It would be waiting for this because we knew that it was a better system thing was something that was a long time in coming. The concept is to mechanically include the appendage reliably and the older version, uh, did that. But it was a little cagey, a little bit sharp. It there were certain anatomies that were riskier. It seals much more reliably than the previous device and is much more stable. So in every way, this does its job much better than the previous watchman did. Testing for the for the FDA, we actually saw a much lower rate off Perry device leak that we used to see with the initial device initial device, or about 33% of repression of some leaks around the device with new device, the watchman flags way see less in less than 5%. So it is a huge difference, and the delivery of the system is much easier for even less experience. Operate also certainly a safer procedure overall way. Go with this large, uh, delivery system in tow, the amount of the appendage on do you take picture to see what is the proper size That's another very critical part of the procedure. Because if you undersized system the appendage and use a small system, then there is a chance that this system is not going to stay there in my dislodge. This would be the device that's inside the delivery sheath and inside its containment sheath. Once you're positioned correctly, you basically just push it right out, and it immediately close is just like that. Then you simply unscrew it on. Leave it another benefit. New device can be recaptured as many times as you want with the old device. If you were captured twice, you need to remove it and use a new one because it become more dangerous. Toe new device can be recaptured as many times as you want, so you really can spend time to optimize the deployment at the but the best side so that you have the best outcome for innovation. Newer device. The biggest advance I think of it is that all of those metal struts actually fullback and connect together. So when this device is partially out, it forms a very soft, a traumatic ball rather than 10 little spikes. It has a ball and eso that alone makes the likelihood of success without mechanical injury to the heart much more likely, you know, being able to now be able to use it for everybody. It's certainly you know, as the doctor is, it's a good feeling.