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Medtronic Evolut TAVR System Receives Expanded Indication to Treat Symptomatic Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality
The expanded indication approval is based on randomized clinical data from the global, prospective, multi-center Evolut Low Risk Trial, which evaluated three valve generations (CoreValve™, Evolut™ R, and Evolut™ PRO valves) in more than 1,400 patients. The data showed TAVR to have an excellent safety profile and be an effective treatment option in low-risk patients with shorter hospitals stays and improved quality-of-life scores compared to SAVR. In addition to a significantly lower rate of the composite of all-cause death or disabling stroke with TAVR at 30 days, the Evolut TAVR system demonstrated superior hemodynamic (blood flow) performance with significantly lower mean aortic valve gradients and larger EOAs (effective orifice area) compared to surgery – important factors for more active patients. The rate of new pacemaker implantation and residual aortic regurgitation was higher in the TAVR group.
“The majority of my patients want a replacement valve that’s going to minimize the risk of death, stroke, and other cardiovascular events during the procedure and allow them to leave the hospital faster and recover sooner. In patients appropriate for a biologic valve, that option is going to be TAVR,” said
The Evolut TAVR System, with its industry-leading hemodynamics, allows for improved heart function that helps many patients resume their pre-aortic stenosis activity levels. The valve is engineered with a self-expanding nitinol frame that conforms the replacement valve to the native annulus with consistent radial force and includes an external tissue wrap that increases surface area contact with native anatomy for enhanced valve sealing. The CoreValve Evolut TAVR platform leads the industry in longer-term data, reporting durability data out to 8 years with the Italian Registry.
“Low risk patients were younger and healthier than those patients enrolled in our prior studies, and were better able to weigh the risks and benefits of surgery or TAVR based on their value preferences,” said
Severe aortic stenosis affects approximately 165,000 low risk patients per year in the U.S.,
“This expanded indication means that physicians and patients will have more freedom to choose the right aortic valve replacement procedure based on each patient’s health and quality-of-life goals, which may vary based on their age, frailty and anticipated daily activity,” said Pieter Kappetein, M.D., Ph.D., vice president and chief medical officer for the Structural Heart and Cardiac Surgery businesses, which are part of the
With the approval, the Evolut TAVR platform is now indicated in the U.S. for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low).
In collaboration with leading clinicians, researchers and scientists worldwide,
Any forward-looking statements are subject to risks and uncertainties such as those described in
Source: Medtronic plc