News | Heart Valve Technology | October 02, 2017

Medtronic Announces Post-Market Study for CoreValve Evolut Pro System

Study designed to assess longer-term clinical performance of next-generation transcatheter aortic valve implantation (TAVI) system

Medtronic Announces Post-Market Study for CoreValve Evolut Pro System

October 2, 2017 — Medtronic recently announced a new post-market clinical study to evaluate its CoreValve Evolut Pro valve in everyday clinical practice. Studying patients with severe symptomatic aortic stenosis at an intermediate, high or extreme risk for open-heart surgery, the FORWARD PRO Clinical Study will evaluate longer-term performance (out to five years) of the next-generation self-expanding transcatheter aortic valve implantation (TAVI) system, which was recently approved for commercial use in Europe and United States.

The Evolut Pro valve, built off the Evolut R platform, is designed with an outer tissue wrap to further advance valve sealing performance. The biocompatible porcine pericardial tissue wrap, in addition to other design elements, is incorporated to address the occurrence of blood leaking through the sides of the valve. The first-ever data for the Evolut Pro valve, presented at the 2017 American College of Cardiology Scientific Sessions (ACC.17), showed no moderate/severe paravalvular leak (0 percent), high rates of survival (98.3 percent) and a low rate of disabling stroke (1.7 percent) at 30 days.

The multi-center, prospective single-arm clinical study will enroll 600 patients across 35 sites in Europe and will evaluate safety, including all-cause mortality and all stroke at 30 days, and clinical performance, including valve hemodynamics and paravalvular regurgitation. Patients will be followed out to five years.

“We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a study designed to look at the valve’s longer-term real-world performance,” said Prof. Eberhard Grube, M.D., director of the Structural Heart Program at University Hospital in Bonn, Germany, and co-principal investigator of the FORWARD PRO Study. “The Evolut Pro has shown exceptional results for patients with severe aortic stenosis and we are excited to enroll our first patients into this rigorous study.”

Watch the VIDEO “TAVR Stands Equal to Surgical Valve Replacement,” an interview with Michael Reardon, M.D., from ACC.17.

For more information: www.medtronic.com

Related Content

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

News | Cardiovascular Clinical Studies | July 22, 2020
July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to re
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp