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

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Montreal Heart Institute Performs First Robotic Mitral Valve Surgery
News | Robotic Systems| September 22, 2017
The Montreal Heart Institute (MHI) announced the acquisition of the da Vinci Xi, a new-generation surgical robot, and...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Overlay Init