Four-Year Data Presented from Medtronic's CoreValve CE Pivotal Study

March 31, 2014—Medtronic, Inc. (Minneapolis, MN) announced that the final follow-up results from the CoreValve CE Pivotal Study were presented at the ACC.14: 63^rd annual scientific session of the American College of Cardiology held in Washington, DC.

According to Medtronic, the study’s 4-year data for patients with severe aortic stenosis who were treated with the company’s self-expanding CoreValve system demonstrated the device’s long-term durability and excellent clinical performance. The results also showed that the significant improvements in quality of life at 1 year were sustained through 4 years, with 74% of patients improving at least one New York Heart Association (NYHA) functional class from baseline to 4 years. Additionally, the rates of regurgitation and stroke remained low, with 83% of patients free from stroke at 4-year follow-up.

The CoreValve CE Pivotal Study is a prospective evaluation of the CoreValve system that reported independent echocardiographic core laboratory–validated, long-term data for transcatheter valve durability. The study enrolled 126 patients at nine centers in Europe and Canada. The study was designed to achieve European CE Mark approval for the CoreValve system to treat patients who were considered too ill or frail to have their aortic valves replaced through surgery, advised the company.

On March 29, Medtronic announced the presentation at ACC.14 of the High Risk Study of the CoreValve US Pivotal Trial, which met its primary endpoint with a 1-year, all-cause mortality rate of 14.2% in patients receiving the CoreValve system, compared to 19.1% in patients receiving surgery (noninferiority P < .001; superiority P = .04).

In January 2014, the US Food and Drug Administration approved the CoreValve system for patients considered at extreme risk for surgery; the device is not currently approved in the United States for use with patients at high risk. The device received European CE Mark approval in 2007.