Medtronic Receives CE Mark for Evolut™ FX Transcatheter Aortic Valve Implantation System

Oct 14, 2023 00:00 CST Updated 00:00

Medtronic

Medical Device Manufacturer

Source of the article:Heart NotCome;Editor:Jacky

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Heart Future

On October 12, 2023, Medtronic (NYSE: MDT) announced that its Evolut™ FX Transcatheter Aortic Valve Implantation (TAVI) System had received the CE (European Standard) Mark.

# About the Evolut™ FX System

The Evolut™ FX system is the latest generation TAVI system in the CoreValve™/Evolut TAVI platform. The Evolut FX system is designed to enhance ease of use and provide clinicians treating severe aortic stenosis patients with greater precision and stronger control throughout the procedure.The Evolut platform is the only TAVI platform that has demonstrated superior durability over SAVR (surgical aortic valve replacement) at 5 and 10 years in randomized trials.

The Evolut FX system adopts the same supra-annular self-expanding valve design as the Evolut platform. According to an independent, large-scale, year-long randomized trial, the system demonstrated superior hemodynamic performance in valve replacement surgeries compared to surgical aortic valve replacement (SAVR).

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The fourth-generation Evolut technology is equipped with built-in metal markers, providing doctors with direct visualization of depth and valve leaflet orientation during the implantation process. This helps doctors accurately position the TAVI catheter or valve implantation device, ensuring precise placement at the patient’s aortic valve location. The position and shape of the metal markers provide crucial reference information to assist doctors in surgical procedures and evaluations. Additionally, the Evolut FX system’s catheter has been redesigned for smoother insertion and offers a more flexible delivery system, enabling stable and predictable implantation.

Dr. Danny Dvir, an interventional cardiologist at Shaare Zedek Hospital, stated that the latest Evolut FX system is enhancing the precision, control, and predictability for doctors performing transcatheter aortic valve replacement in patients with severe aortic stenosis. The system provides physicians with an innovative solution to meet the needs of patients who wish to quickly return to an active lifestyle.

# Evolut™ FX System to Launch in Europe Soon

Severe aortic stenosis occurs when the aortic valve leaflets thicken and become stiff, making it difficult to open and close, causing the heart to work harder to pump blood to the rest of the body. Severe aortic stenosis often reduces the patient's quality of life and limits their daily activities.If not treated in time, patients with symptomatic severe aortic stenosis may die of heart failure within as little as two years.

Jeffrey Popma, MD, Vice President and Chief Medical Officer of Medtronic's Coronary and Renal Denervation Business and Structural Heart and Aortic Business, stated that achieving the CE mark represents an exciting milestone that helps the company continue to strengthen a trusted platform to better meet the needs of clinicians, making TAVI procedures easier, more visual, and more predictable for heart teams. The Evolut FX system receiving the CE mark underscores the company’s commitment to providing minimally invasive treatment options globally for patients with severe aortic stenosis.

The Evolut FX system is indicated for severe aortic stenosis in adult patients across all risk categories (extreme, high, intermediate, and low) in the EU and for symptomatic severe aortic stenosis across all risk categories in the U.S. The system is expected to become available across Europe in the coming weeks as teams and physicians are trained on this new technology.

# About Medtronic

Medtronic is a global leading medical technology company, established in 1949, with its headquarters in Minneapolis, Minnesota, USA. The company is mainly dedicated to providing lifelong treatment, diagnosis, and monitoring solutions for patients with chronic diseases such as cardiovascular diseases, neurology, diabetes, and spinal disorders.

On February 21, 2023, Medtronic announced its third-quarter financial report, showing continued growth momentum. As of January 27, 2023, Medtronic's revenue reached $7.727 billion, a year-on-year increase of 4%, with a profit of $1.22 billion.

Cardiovascular business revenue was $2.772 billion, an increase of 1%, with organic growth of 7%. The cardiovascular business portfolio includes arrhythmia and heart failure, structural heart and aortic, coronary and peripheral vascular. Arrhythmia and heart failure, as well as structural heart and aortic, achieved high single-digit growth. Coronary and peripheral vascular had low single-digit growth, while the revenue of the coronary and peripheral vascular division experienced high single-digit growth.

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