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July 1, 2020

Medtronic wins CE mark for Evolut TAVR system in low-risk patients

By GlobalData Healthcare

On 22 June, Medtronic announced that it received a CE mark for its Evolut Transcatheter Aortic Valve Replacement (TAVR) system for use in low-risk patients. The positive news comes as restrictions put in place due to the Covid-19 pandemic begin to ease in some countries, while caseloads worsen in others.

TAVR is a minimally invasive method for replacing a diseased aortic valve in patients who suffer from severe aortic stenosis. The procedure serves as an alternative to surgical valve replacement and is intended for patients who are at risk for open surgical interventions due to age, frailty, or other reasons. Two manufacturers hold the grand majority of global market share for TAVR devices: Edwards LifeSciences with its Sapien brand of valves and Medtronic with its Evolut brand.

When the Sapien and Evolut valves were first released, both were only indicated for the treatment of patients with severe aortic stenosis who were at extreme risk for surgical intervention. Since then, both valves have had their indications expanded through the Food and Drug Administration (FDA) approval in the US to include patients at intermediate surgical risk and low surgical risk. The expanded indication for low surgical risk patients came shortly after clinical trial results were released for both valves at the American College of Cardiology conference in early 2019.

Medtronic’s Evolut valve has now also received CE mark approval for use in the low surgical risk population. Edwards’s Sapien valve received CE mark approval for use in the low surgical risk population first in November 2019. Before the approvals, GlobalData had estimated that the European market value for TAVR devices was just under $1.5bn in 2019. However, given the expanded patient pool that can now be treated with the devices, the market value in Europe will likely grow significantly in the coming years.

The regulatory approval comes at a time when many European countries are facing dwindling Covid-19 case numbers and are loosening regulations that were put in place during the Covid-19 pandemic. As the regulations ease, procedures such as TAVR are beginning to return to their normal pre-pandemic levels. Therefore, Medtronic’s expanded indication for its Evolut valve in Europe comes at a good time, since European physicians will likely soon be increasing the number of TAVR procedures they are performing.

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