Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Medtronic Expands TAVR Access To More Patients With Symptomatic, Severe Aortic Stenosis Upon Intermediate Risk FDA Approval

July 17, 2017 By Medtronic

Medtronic has announced the expanded FDA approval of the self-expanding CoreValve Evolut transcatheter aortic valve replacement (TAVR) platform to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery. With hemodynamic performance (a measure of blood flow efficiency) shown to be superior to surgical aortic valve replacement (SAVR), the CoreValve Evolut platform is designed to deliver excellent valve performance for these patients who are often considered to be more active than high- or extreme-risk patients previously indicated for the procedure.

Patients who are at intermediate risk for open-heart surgery have a risk of mortality of >= 3 percent at 30 days following the procedure. The risk assessment is determined by a heart team (including an interventional cardiologist and cardiac surgeon), in combination with the Society of Thoracic Surgeons (STS) score and other factors, such as co-morbidities, frailty, prior surgical intervention, and disabilities.

“As evidenced by the landmark SURTAVI trial, the CoreValve Evolut platform is well-suited for the intermediate-risk patient population due to its supra-annular design for unsurpassed hemodynamics, low rates of mortality and disabling stroke, earlier improvement in quality of life, fast functional recovery times and short hospital stays,” says Michael Reardon, MD, professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist DeBakey Heart & Vascular Center. “It’s important to consider that in the first 30 days, patients treated with TAVR showed functional improvements and lower rates of stroke than the surgical patients in the study.”

The CoreValve Evolut R. (Image credit: Medtronic)

Recently unveiled at the 2017 American College of Cardiology meeting, the global SURTAVI trial evaluated intermediate-risk patients and compared 863 TAVR patients treated with the CoreValve and Evolut R Systems (STS: 4.4 percent) to 794 surgical patients (STS: 4.5 percent). Against the strongest surgical performance (compared to predicted surgical risk of mortality) seen to date in a randomized trial, the CoreValve Evolut platform met its primary endpoint of non-inferiority compared to surgery in all-cause mortality or disabling stroke (12.6 percent for TAVR versus 14.0 percent for SAVR; posterior probability of non-inferiority >0.999). The CoreValve Evolut platform also demonstrated significantly better mean aortic valve gradients (7.8 mm Hg vs. 11.8 mm Hg; p<0.001) at two years. SAVR was associated with less aortic regurgitation, major vascular complications and need for permanent pacemaker implantation.

“Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population,” says Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, a part of Medtronic’s Cardiac and Vascular Group. “We are delighted to take the self-expanding CoreValve Evolut platform to more patients with aortic stenosis who can benefit from this therapy.”

The CoreValve Evolut platform consists of the CoreValve, CoreValve Evolut R, and the recently FDA-approved CoreValve Evolut PRO systems, which are available for use in the United States with severe aortic stenosis patients at an intermediate surgical risk or greater. The CoreValve Evolut PRO System is currently not approved for commercial use outside of the United States.

Related Articles Read More >

Medtronic Hugo robot-assisted surgery system
The road to a robot: Medtronic’s development process for its Hugo RAS system
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A portrait of Stryker executive Tracy Robertson
Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’
gBETA Medtech accelerator picks its next startups

DeviceTalks Weekly.

May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech