Edwards Lifesciences received European CE Mark approval for its SAPIEN 3 Ultra transcatheter aortic heart valve. Indicated for valve replacement in patients with severe, symptomatic aortic stenosis, the device is available in three sizes (20 mm, 23 mm, and 26 mm) to fit most anatomies. It sports modifications to the valve itself, as well as an all-new delivery system and sheath, in order to be able to treat patients for whom other transcatheter aortic valve systems are not appropriate.
The SAPIEN 3 Ultra features an extended skirt on its exterior that helps to avoid leakages and a 14-French low profile sheath. The delivery system uses an “on balloon” design that doesn’t require the surgeon to have to manually align the artificial valve with the native anatomy. This helps to speed up procedures, reducing risks for patients and saving money for hospitals.
“The SAPIEN 3 Ultra system incorporates enhancements to the valve, as well as a new delivery system, which are designed to further build on the exceptional outcomes of the SAPIEN 3 valve, which has shown extremely low rates of mortality and disabling stroke,” in a statement said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves. “With the SAPIEN 3 Ultra system, we are building on our best-in-class performance to further advance and improve patient care.”
The device is not yet approved in the U.S. and its launch in Europe is under question. Here’s some details according to Edwards:
As previously announced, Edwards will introduce the SAPIEN 3 Ultra system in Europe as part of a controlled rollout, which includes training, to ensure high procedural success of this advanced valve and delivery system.
The SAPIEN 3 Ultra system will not be launched at this time in Germany, as a result of the preliminary injunction that Boston Scientific chose to implement in the country. Edwards is disappointed in Boston Scientific’s tactic to limit access of this new therapy. The German court will hold a full hearing on the merits of the dispute in mid-2019, and Edwards continues to believe that it will ultimately prevail in this matter. The SAPIEN 3 and CENTERA valve systems remain available in Europe. The German case pertains to a European patent that Boston acquired in 2017 (No. EP 2 949 292).