Edwards Lifesciences (NYSE:EW) today announced that Health Canada has approved the expanded use of the company’s Sapien 3 and Sapien 3 Ultra transcatheter heart valves to treat patients diagnosed with severe symptomatic aortic stenosis who are at low risk for open-heart surgery.
The Sapien 3 valves are the first transcatheter aortic valve replacement (TAVR) systems to have this indication in Canada. Canadian authorities previously approved Sapien 3 for the treatment of patients suffering from severe, symptomatic aortic stenosis (AS) who are at high risk for or unable to undergo open-heart surgery. Severe aortic stenosis is a debilitating disease that often goes undiagnosed and is undertreated.
The latest approval is based on data from the independently evaluated, randomized clinical Partner 3 trial, which reported a 46% lower event rate for death from any cause, stroke or rehospitalization at 1 year after TAVI compared to open-heart surgery. Patients treated with Sapien 3 valve experienced 1.0% rates of death or disabling stroke at 1 year, a short length of stay and 96% discharged to home or self-care, the study showed. Patients also reported significant improvements to health status and quality of life as early as 1 month after the procedure — findings that were sustained out to 12 months post-procedure, according to a news release.
“Now, all Canadian patients diagnosed with aortic stenosis can be considered for (TAVR) with the Sapien 3 valves based on individual needs rather than risk scores,” said Dr. John Webb, director of interventional cardiology and cardiac catheterization laboratories at St. Paul’s Hospital, Vancouver, and professor of cardiology at the University of British Columbia. “Previously, their only treatment option was open-heart surgery, so this approval is particularly important for patients at low risk for surgery, whose only serious health issue may be aortic stenosis and who desire a quick return home and to their everyday activities.”