The CE mark has been granted to the Sapien 3 Ultra (Edwards Lifesciences) transcatheter aortic valve implantation (TAVI) device, but a dispute between Edwards Lifesciences and Boston Scientific over a patent means that—for the moment—the device will not be launched in Germany. Germany is the biggest market in Western Europe.
A press release reports that the Sapien 3 Ultra system (valve sizes 20, 23 and 26mm) features enhancements to the valve, and a new delivery system and sheath. The valve features a heightened outer skirt designed to eliminate paravalvular leak. It adds that the valve also consists of a new low-profile 14Fr Axela expandable sheath and introduces an “on balloon” design, which removes the need for valve alignment during the procedure.
John Webb (St Paul’s Hospital, Vancouver, Canada), says: “The Edwards Sapien 3 Ultra system incorporates features designed to help simplify and improve the efficiency of the procedure. This design innovation represents a meaningful advancement over previous generations of this technology.”
According to the press release, the system builds on Edwards’ decades of engineering and experience in the development of tissue heart valves, and the proven benefits of the Edwards Sapien valves. However while the company 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, it not be launch the valve at this time in Germany as a result of a preliminary injunction that Boston Scientific chose to implement in the country.
In October, the District Court of Dusseldorf, Germany, had ruled that the Sapien 3 Ultra had infringed a patent that was established by Symetis (now part of Boston Scientific). According to Boston Scientific, the patent related to the fabric used on the valve seal “specifically the German part of the European Patent (EP) 2 949 292 B1”. The Dusseldorf Court ruled, in a preliminary injunction, that Boston Scientific has the right to enjoin Edwards and its Germany subsidiary from offering and selling Sapien 3 Ultra in Germany.
Edwards Lifesciences, as outlined in the press release announcing the CE mark for Sapien 3 Ultra, 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 states that it continues to believe that “it will ultimately prevail in this matter”. The Sapien 3 and Centera valve systems remain available in Europe.
Larry L Wood, Edwards’ corporate vice president, transcatheter heart valves, says: “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. With the Sapien 3 Ultra system, we are building on our best-in-class performance to further advance and improve patient care.”
The Sapien 3 Ultra system is not approved in the USA; Edwards previously discussed that it anticipates it will receive US FDA approval for the Sapien 3 Ultra system around the end of 2018.