FDA Approval of Medtronic TAVR System

Evolut PRO+ TAVR System Product, Courtesy of Medtronic

As a global leader in heart valve therapy, Medtronic recently announced the FDA approval of its Evolut PRO+ System. This clearance provides a new form of treatment for patients suffering from symptomatic severe aortic stenosis with a low risk of surgical mortality.

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Severe aortic stenosis is when the aortic valve leaflets have difficulty opening and closing. This is due to the leaflets becoming stiff and thickened, making the heart work harder to pump blood to the rest of the body. This can ultimately result in patients dying from heart failure in as little as two years. Medtronic’s new generation of TAVR System includes four valve sizes with an external pericardial tissue wrap. The Evolut PRO+ delivers advanced sealing for the largest indicated patient treatment range and the lowest delivery profile currently on the market.

In-depth analysis from iData Research has found that as the age of the population increases, procedural volumes in the cardiac surgery market will increase accordingly. Cardiac diseases tend to afflict the elderly at a higher rate than younger individuals. As baby boomers advance in age, a large portion of the population will be at an increased risk of experiencing heart failure. The increased procedural volume, combined with the high ASP of new product innovation from organizations like Medtronic is expected to drive growth in minimally invasive spine surgery.

According to Guilherme Attizzani, M.D., an interventional cardiologist and director of the Valve and Structural Heart Disease Center at University Hospitals in Cleveland, “physicians are treating a broader range of patient anatomies than ever before – from large to small, from simple to complex. Adding the external tissue wrap to the large 34mm valve size, which wasn’t previously available, is a major technological improvement that will benefit many patients with larger anatomies.”

The Evolut PRO+ TAVR System has also launched in the U.S. since it received FDA approval. “As TAVR becomes a preferred treatment option for more patients with severe aortic stenosis, it’s critically important to have valve technology available that keeps pace with the evolution of the therapy,” said Mathew R. Williams, M.D., director of the Heart Valve Program at the NYU Langone Health in New York City.


For Further Information

To get in an in-depth market overview of 23 countries, with insight through primary research and procedural volumes, please read iData Research’s Cardiac Surgery and Heart Valve Devices Market Analysis, Size and Trends Report.

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