News | Heart Valve Technology | June 09, 2015

Medtronic CoreValve Evolut R System Yields Positive Outcomes in First Clinical Study

Recapturable valve shows no mortality or stroke at 30 days

Medtronic, CoreValve Evolut R, first clinical study, ACC.15

June 9, 2015 - Medtronic plc announced initial clinical outcomes for its next-generation CoreValve Evolut R System at the 64th annual scientific session of the American College of Cardiology, March 14-16 in San Diego. At 30-days, the recapturable, self-expanding valve showed no incidents of all-cause mortality or stroke in a high and extreme risk patient population. The Evolut R Study enrolled 60 patients from six centers in the United Kingdom, Australia and New Zealand.

The system is not approved for commercial use in the United States, where it is currently undergoing clinical trials.

"Initial clinical experience with the Evolut R system is remarkable and ushers in a new era of TAVR [transcatheter aortic valve replacement] technology that provides increased confidence with recapturability, excellent procedural results and impressive clinical outcomes," said Ian Meredith, M.D., of Monash Heart - Monash Health, Melbourne, Australia,  who is a co-principal investigator of the study. "The 14 French equivalent delivery system allowed transfemoral access for most patients and the recapturable technology enabled implanters to optimize valve placement for improved annular sealing and reduced conduction disturbances without compromise on mortality or stroke."

The EnVeo R Delivery Catheter System provides a new InLine Sheath that significantly reduces the profile to a 14 Fr equivalent, less than 1/5 inch. Transfemoral access was possible in all but one patient (98.3 percent) in a population that included patients with vasculature as small as 5mm diameter. All recapture attempts were performed safely with zero strokes (0.0 percent). Additionally, correct valve position with one device was achieved in 98.3 percent of patients, and there were no cases of valve dysfunction, procedural death, annular rupture, coronary occlusion, valve embolization or conversion to surgery in the study. The pacemaker rate was low at 11.7 percent.

The supra-annular valve design of the CoreValve Evolut R System resulted in low, single-digit mean aortic gradients (a commonly used threshold of exceptional blood flow) at each follow-up visit (9.2mm Hg in early follow-up at 24hrs to 7 days post-procedure, and 8.1mmHg at 30 days). The valve features a new extended sealing skirt on the 26 and 29 mm sizes that further promotes valve sealing at the annulus, resulting in low rates of paravalvular leak (PVL) with 96.6 percent of patients having ≤ mild PVL at 30-days.

The 23 mm, 26 mm and 29 mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery Catheter System are available in Europe and other countries that recognize the CE mark.

For more information: www.medtronic.com

Related Content

Boston Scientific Prevails in U.S. Edwards Lifesciences Litigation
Feature | Heart Valve Technology | December 12, 2018
A jury in the U.S. District Court for the District of Delaware determined Dec. 11 that the Boston Scientific U.S....
First TriCinch Coil Tricuspid Repair Systems Implanted in U.S.
News | Heart Valve Technology | November 06, 2018
4Tech Inc. initiated its U.S. Early Feasibility Study of the TriCinich Coil System following U.S. Food and Drug...
Valve Replacement Volume Key to Successful Patient Outcomes
News | Heart Valve Technology | November 02, 2018
Hospitals that routinely perform a heart valve replacement procedure requiring open heart surgery are more likely to...
Prosthetic Valve Mismatches Common in TAVR Procedures
News | Heart Valve Technology | October 03, 2018
A high number of patients in a study who underwent transcatheter aortic valve replacement (TAVR) experienced severe and...
Local Anesthesia Safe and Effective for Intermediate- and High-Risk TAVR Patients
News | Heart Valve Technology | September 28, 2018
The first randomized study to compare general versus local anesthesia during transcatheter aortic valve replacement (...
MitraClip Reduces Mortality for Heart Failure Patients With Secondary Mitral Regurgitation
News | Heart Valve Technology | September 26, 2018
Patients with heart failure and secondary mitral regurgitation (MR) who remained symptomatic despite maximally...
Ancora Heart Announces Positive Interim Analysis of AccuCinch Ventricular Repair System for Heart Failure
News | Heart Valve Technology | September 24, 2018
Ancora Heart Inc. announced positive clinical data from the company’s recently expanded U.S. early feasibility study...
Medtronic Announces TAVR Study of Aortic Stenosis Patients With Bicuspid Valves
News | Heart Valve Technology | September 19, 2018
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a new...
4C Medical's AltaValve First-in-Human Experience to be Presented at TCT 2018
News | Heart Valve Technology | September 17, 2018
September 17, 2018 — 4C Medical Technologies Inc.
Overlay Init