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June 22, 2020

Medtronic Evolut TAVR System Receives Approval for Low-Risk Indication in Europe

June 22, 2020—Medtronic announced CE Mark approval and the European launch of the Evolut system for transcatheter aortic valve replacement (TAVR) in patients with severe native aortic stenosis who are at a low risk of surgical mortality.

Additionally, the Evolut TAVR platform received approval for a new indication that allows for the treatment of patients with bicuspid aortic valves who are at intermediate, high, and extreme risk of surgical mortality.

According to Medtronic, the low-risk patient population is the final surgical risk category to be approved for this alternative to surgical aortic valve replacement (SAVR) and includes patients who may be younger and more active than higher-risk patients, noted the company.

The expanded low-risk indication approval is based on clinical data from the global, prospective, randomized, multicenter Evolut Low-Risk trial, which evaluated three generations of Medtronic valves (CoreValve, Evolut R, and Evolut Pro) against SAVR in more than 1,400 patients.

In March 2019, the company announced the presentation of this 24-month data by senior investigator Michael J. Reardon, MD, at the American College of Cardiology's 68th Annual Scientific Session in New Orleans, Louisiana. The data were concurrently published by Jeffrey J. Popma, MD, et al in The New England Journal of Medicine (2019; 380:1706-1715).

According to Medtronic, the data showed TAVR to have an excellent safety profile and be an effective treatment option in low-risk patients with shorter hospital stays and improved 30-day quality-of-life scores compared with SAVR.

In addition to a lower rate of the composite of all-cause death or disabling stroke with TAVR at 30 days, the Evolut system demonstrated superior hemodynamic performance with significantly lower mean aortic valve gradients and larger effective orifice area compared with surgery at 1 year; these factors that may be important for more active patients. The rate of new pacemaker implantation and residual aortic regurgitation was higher in the TAVR group, noted the company.

With this approval, the Evolut TAVR platform is now indicated in Europe for severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low), and includes new labeling that allows for the treatment of patients with bicuspid aortic valves for patients at extreme, high, and intermediate risk of surgical mortality.

“The low-risk indication marks an important milestone for patients across Europe as TAVR expands into a potentially younger and more active patient population,” commented Evolut Low-Risk trial investigator Thomas Modine, MD, in Medtronic's press release. “While surgical valve replacement will still be an option for many patients, we anticipate TAVR to be accepted as an important valve replacement therapy in patients for whom it is an appropriate treatment option. Heart teams will have more freedom to choose the best aortic valve replacement procedure based on each patient’s individual characteristics.” Dr. Modine is a cardiac surgeon at Hôpital Cardiologique Lille, in Lille, France.

Didier Tchétché, MD, an Evolut Low-Risk trial investigator, added, “It is important that we expand access to a less invasive treatment option to this low-risk patient population. It’s also encouraging that we now have new labeling to address a large portion of bicuspid valve patients, too. Based on excellent data from the STS/ACC TVT Registry, bicuspid patients (excluding low risk), will for the first time, be indicated for TAVR, which is another big win for patients and the future of the therapy.” Dr. Tchétché is an interventional cardiologist and Director of the Structural Heart Disease Department at Clinique Pasteur in Toulouse, France.

In the United States, the Evolut TAVR platform is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low). Bicuspid valve patients at intermediate risk or higher may be candidates for TAVR in the United States, advised Medtronic.

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