Edwards Lifesciences received FDA approval to introduce its SAPIEN 3 Ultra transcatheter aortic heart valve in the U.S. Specifically, the device is indicated for cases of severe, symptomatic aortic stenosis identified to be at intermediate or greater risk of open-heart surgery.
The SAPIEN 3 Ultra has some modifications that make it appropriate to a wider range of patients that would otherwise not be able to get a transcatheter aortic valve. And a brand new delivery system and sheath make the implantation procedure a bit easier on the physicians.
The valve 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.
European authorities approved the device in November, but as we reported then, Edwards noted that it had a serious legal roadblock to jump over in Germany:
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).