Medtronic Announces Positive Four-Year Data from Evolut TAVR Low-Risk Trial

# Medtronic Evolut TAVR Outperforms Surgical Valve Replacement in Study

MedtronicForce CompanyAnnounced on October 24Its Evolut Transcatheter AorticFour-Year Positive Results of the Low-Risk Trial for the TAVR System.Medtronic Evolut™ Transcatheter Aortic Valve Replacement (TAVR) System Demonstrates Superior Outcomes and Sustained Valve Performance, with Hemodynamics Significantly Better than Surgical Aortic Valve Replacement (SAVR).

Evolut TAVR reports that, compared with the most advanced surgery, patients receivingFour-Year Outcomes of Evolut TAVR TreatmentThe mortality rate or incidence of disabling stroke remained consistently low. The data were presented at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference (the Cardiovascular Research Foundation’s annual scientific symposium) and simultaneously published in the Journal of the American College of Cardiology.

"Allison Family Distinguished Chair in Cardiovascular Research, Professor of Cardiothoracic Surgery at Houston Methodist Hospital, and principal investigator of the trial, Dr. Michael Reardon, stated: 'Since TAVR was approved for low-risk surgical patients, we have needed evidence to better understand the mid-term and long-term durability of TAVR devices with different designs. Compared with surgery, we have seen patients in the Evolut Low Risk Trial continue to demonstrate positive outcomes and sustained valve performance, which helps us establish mid-term evidence for the Evolut TAVR and contributes to determining the long-term situation. These results are not only encouraging but also critical for treatment decisions in low-risk patients with severe aortic stenosis symptoms. We observe that patients treated with the Evolut TAVR achieve sustained, excellent valve performance, which will ultimately translate into improved clinical outcomes, including reduced mortality and disabling stroke rates.'"

# Data from Medtronic

The Evolut™ Low Risk Trial is a prospective, randomized, multicenter study designed to evaluate the safety and efficacy of the Evolut TAVR system compared to surgical aortic valve replacement (SAVR) in low-risk patients. In the trial, low-risk patients are defined as those with a predicted risk of 30-day mortality <3%, and these patients are randomly assigned to undergo TAVR using Medtronic's self-expanding supra-annular Evolut R, PRO, or CoreValve.™ Bioprosthesis and SAVR Study. A total of 1,414 patients attempted implantation (730 TAVR; 684 SAVR).

The study shows that, compared with SAVR, Evolut TAVR has continued to achieve positive results in the primary endpoint of all-cause mortality or disabling stroke over four years. At the four-year mark, the study found a 26% relative reduction in the risk of death or disabling stroke with TAVR (10.7%) compared to 14.1% in the SAVR group. The absolute difference between the treatment groups for the primary endpoint continued to increase over time. The persistent increase in absolute difference between treatment groups over time suggests greater clinical benefit for patients receiving Evolut TAVR compared to surgery after four years. Study results also showed that the composite rate of all-cause mortality, disabling stroke, or aortic valve rehospitalization was 18.0% in the TAVR group, compared to 22.4% in the SAVR group.

# 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 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).

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.

BeautyMedtronic is a global leaderAdvanced medical technology company, establishedFounded in 1949, with its headquarters located in Minneapolis, Minnesota, USA. The company is mainly committed toProvide lifelong treatment, diagnosis, and monitoring solutions for patients with chronic diseases such as cardiovascular disease, neurology, diabetes, and spinal conditions.

2On February 21, 2023, Medtronic announced its third-quarter financial report, and the company's growth momentum continued.As of January 27, 2023, Medtronic's revenue was $7.727 billion, a year-over-year increase of 4%, with a profit of $1.22 billion.