9. Edwards Lifesciences
R&D Spending: $752,700,000
Percentage of revenue: 17.3%
2020 overall ranking: 26
In February 2109, Edwards Lifesciences won CE Mark approval for its Pascal transcatheter valve repair system. The system is designed to treat mitral regurgitation while maintaining native anatomy. It features contoured, broad paddles to maximize coaptation of the mitral leaflets and a central spacer to fill the regurgitant orifice area. The newly launched system also includes a delivery system intended for independent leaflet capture to optimize leaflet position.
Edwards won FDA clearance in August 2019 for its smart cable to connect a brain oxygenation sensor with its hemisphere patient monitor.The following November, Edwards won CE Mark approval for the expanded use of its Sapien 3 transcatheter aortic valve implantation system. The expanded use was for the treatment of patients with aortic stenosis who are at low risk for open-heart surgery. The valve indication expansion followed the publican of data from a Partner 3 pivotal trial earlier that year in the New England Journal of Medicine. That trial showed the Sapien 3 TAVI system achieved a 46% reduction in the event rate for the primary endpoint of the trial (composite of all-cause mortality, all stroke and rehospitalization at one year).
Edwards matched its Q3 2020 R&D spending to the same quarter last year, at $195.5 million. For the first nine months of 2020, Edwards spent $565 million on R&D, up from $558.8 million for the same period of 2019.
In May 2020, Edwards announced that it received CE Mark approval for its Pascal system for treating tricuspid regurgitation. Pascal is not yet approved in the U.S., although it did receive CE Mark approval for treating mitral regurgitation in February 2019. The FDA approved the company’s Konect Resilia aortic valved conduit (AVC) in July 2020.