A minimally invasive procedure called Transcatheter Aortic Valve Replacement (TAVR) is currently being used for patients that are considered rather unlikely to survive an open heart surgery. These patients are at an intermediate risk of complications.
TAVR involves threading the valve into place through blood vessels using a catheter. Medtronic Plc also sells TAVR systems in the United States.
The Sapien 3 study found that 4.6 percent of patients who received Edwards’ valve had a stroke and 7.4 percent died within a year of their procedure. Among surgery patients, 8.2 percent suffered a stroke and 13 percent died.
The findings of this study will be used by Edwards Lifesciences’ to seek U.S. regulatory approval.
The Sapien 3 study compared 1,078 TAVR patients with outcomes for 944 patients who had open heart surgery in a related trial called Partner II. The Partner II study, presented on Saturday, showed Edwards’ older-model Sapien XT valve was as effective as surgery in intermediate-risk patients.
Edwards Lifesciences is up nearly 15% in the first half hour of Monday’s trading session.
i can’t believe i didn’t see this coming. boy did i miss an opportunity.