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Medtronic (MDT) Receives FDA Nod for Evolut FX TAVR System

Medtronic's (MDT) Evolut FX TAVR system offers hemodynamic and durability benefits of the Evolut platform with new product and procedure enhancements.

This story originally appeared on Zacks

Medtronic plc MDT recently gained FDA approval for its Evolut FX TAVR system. The Evolut FX system is Medtronic’s latest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system. This system is designed to enhance ease-of-use and provide greater precision and control throughout the procedure.

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The Evolut FX system maintains the industry-leading hemodynamic (blood flow) and durability benefits of the Evolut TAVR platform, while bringing product and procedure innovation for patients with symptomatic severe aortic stenosis.

The recent FDA go-ahead for the Evolut FX system is expected to bolster Medtronic’s Cardiovascular portfolio.

The Evolut FX is slated for a limited commercial release during the fall season with a full launch expected in early 2022.

Features in Detail

The Evolut FX system’s supra-annular valve design has demonstrated a superior hemodynamic performance over surgical aortic valve replacement (SAVR) across large-scale, randomized clinical trials.

The Evolut FX system is the fourth-generation Evolut technology. This system is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet location during implant.

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Additionally, the Evolut FX system incorporates a redesigned catheter tip for a smoother insertion profile, a more flexible delivery system that permits 360-degree freedom of motion, with a stable, predictable deployment. This system also includes four valve sizes for the largest indicated patient treatment range and the lowest delivery profile currently on the market, similar to its predecessor (EvolutPRO+).

More in the News

The Evolut FX system is part of the Evolut TAVR platform, which includes the Evolut R, Evolut PRO and Evolut PRO+. The Evolut TAVR platform is indicated for symptomatic severe aortic stenosis patients across all risk categories in the United States. Per management, the Evolut FX system refines the trusted Evolut platform with key product and procedural enhancements.

Industry Prospects

Per a report published in Research and Markets, the global aortic valve replacement market is expected to see a CAGR of 11.1% during 2018-2025. Factors driving market growth include increasing incidence of aortic stenosis coupled with improving treatment rates, surge in geriatric population, rising preference for minimally-invasive surgeries, advancements in aortic valves and favorable reimbursement policies. Further, several  clinical studies undertaken by key players for extending interventional scope, analyzing safety of devices and assessing subsequent treatment alternatives are also propelling market growth.

Given the substantial market prospects, the recent FDA authorization for Medtronic’s Evolut FX TAVR system seems well-timed.

Notable Developments

In August 2021, Medtronic announced its decision to acquire all outstanding shares of Intersect ENT for an enterprise value of approximately $1.1 billion, in an all-cash transaction. This buyout expands Medtronic’s portfolio of products used during ear, nose and throat procedures.

In July 2021, the company announced the first gynecological (GYN) procedures performed with the Hugo robotic-assisted surgery (RAS) system at Pacifica Salud Hospital in Panama City, Panama. The first GYN procedures with the Hugo RAS system include six cases of hysterectomies and myomectomies. Notably, Pacifica Salud is the latest entrant to Medtronic's Partners in Possibility Program.

In the same month, Medtronic launched the Prevail drug coated balloon (DCB) Catheter in Europe following the receipt of CE mark authorization of the same. The Prevail DCB is utilized during percutaneous coronary intervention procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease.

Share Price Performance

The stock has outperformed its industry over the past year. It has grown 27.4% compared to the industry’s 10.4% growth.

Zacks Rank and Key Picks

Currently, Medtronic carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the Medical-Products industry include VAREX IMAGING VREX, Envista Holdings Corporation NVST and BellRing Brands, Inc. BRBR.

VAREX, sporting a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 5%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Envista Holdings, sporting a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 27.4%.

BellRing Brands, which carries a Zacks Rank #2, has a long-term earnings growth rate of 29.1%.

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Medtronic PLC (MDT): Free Stock Analysis Report


VAREX IMAGING (VREX): Free Stock Analysis Report


Envista Holdings Corporation (NVST): Free Stock Analysis Report


BellRing Brands, Inc. (BRBR): Free Stock Analysis Report


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