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August 25, 2021

FDA approves Medtronic’s new TAVR system for aortic stenosis treatment

By offering high accuracy and control during the procedure, the device can preserve blood flow.

The US Food and Drug Administration (FDA) has approved Medtronic’s latest self-expanding transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.

The Evolut FX TAVR system can offer easy usage as well as increased accuracy and control during procedures and incorporates the hemodynamic, or blood flow, and durability advantages of the Evolut platform.

The device uses the supra-annular valve design that has demonstrated superior haemodynamic performance as against surgical aortic valve replacement (SAVR) in large-scale, randomised clinical trials.

The fourth-generation Evolut technology has gold markers in the frame to offer doctors a direct visualisation of depth and valve leaflet position during implantation.

Furthermore, the system combines steady and predictable implementation with an improvised catheter tip, which provides easy insertion and a flexible delivery system permitting 360-degree freedom of motion.

Apart from Evolut FX, Medtronic’s Evolut TAVR platform comprises Evolut R, Evolut PRO and Evolut PRO+ and is intended for all risk categories of patients with symptomatic severe aortic stenosis in the US.

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Similar to Evolut PRO+, the Evolut FX TAVR system has four valve sizes for the primarily indicated patient treatment range and the reduced delivery profile presently on the market.

Initially, Medtronic intends to unveil the platform in a limited commercial release over the coming months, with a full launch expected early next year.

Medtronic coronary, renal denervation and structural heart businesses vice-president and chief medical officer Jeffrey Popma said: “The self-expanding, supra-annular Evolut platform has evolved considerably over time and has brought heart teams innovative features like recapturability, an expanded size matrix, and advanced valve sealing to help minimise the paravalvular leak.

“Today, the Evolut FX system further refines a trusted platform with key product and procedural enhancements that make the self-expanding system easier to use with enhanced visualisation capabilities for orientation and depth.”

Severe aortic stenosis happens when the aortic valve leaflets turn stiff and thickened and have trouble in opening and closing. This leads to the heart working harder to pump blood to the rest of the body.

Meanwhile, the company has reported global revenue of $7.99bn in the first quarter (Q1) of the fiscal year 2022 (FY2022), a growth of 23% on reported and 19% on an organic basis.

For the Q1 ended 30 July 2021, the GAAP net income and diluted earnings per share (EPS) rose by 57% and 56% to $763m and $0.56, respectively.

Earlier this month, Medtronic signed a definitive agreement to acquire all outstanding shares of Intersect ENT for $28.25 per share, or an enterprise value of nearly $1.1bn, in an all-cash deal.

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