Edwards Lifesciences Corp. (EW), Sunday said that results from a study demonstrated similar results in mortality and major clinical events between the Edwards' Sapien XT transcatheter aortic valve and the Edwards Sapien valve.
The trial called Partner II was studying transcatheter aortic valve replacement in inoperable patients with severe, symptomatic aortic stenosis.
The Partner II trial enrolled 560 patients deemed inoperable for traditional open-heart surgery at 28 hospitals in the US between April 2011 and February 2012. Patients were randomized to receive one of the two Edwards transcatheter aortic heart valves: 276 received the SAPIEN valve, and 284 received the Sapien XT valve.
The FDA approved the Sapien valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012. The Sapien XT valve is an investigational device not yet available commercially in the US.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.