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

CE Mark and European Launch of TAVI System

January 17, 2017 By Medtronic

Medtronic announced the CE mark and European launch of the CoreValve Evolut R 34 mm valve—the largest sized transcatheter aortic valve implantation (TAVI) system available in Europe. The new Evolut R 34 mm valve is approved for severe aortic stenosis patients who are at intermediate, high or extreme risk for surgery with an annulus size ranging from 26 to 30 mm.

This large valve segment is estimated to account for approximately 20 to 25 percent of the eligible European TAVI patient population.

Previously, some of these patients were unable to receive a TAVI due to the larger size of their native diseased aortic valve.

“It’s important that patients with large aortic root anatomies can also have access to this recapturable TAVI system, which has proven to be an excellent treatment option for many patients,” says Darren Mylotte, M.D., interventional cardiologist at the University Hospitals and National University of Ireland in Galway, Ireland. “Consistent with the Evolut R platform, the 34 mm valve delivery system assists with accurate placement with the option to recapture and reposition if needed; this gives physicians great confidence that exceptional outcomes can be achieved for our patients.”

(Credit: Medtronic)

The Evolut R 34mm valve is delivered through the EnVe R Delivery Catheter System, which features an InLine Sheath. The system delivers the lowest, true delivery profile currently on the market (16 Fr equivalent, approximately 1/5 inch or 1/2 cm), which provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route. The Evolut R System, with its self-expanding nitinol frame, is designed to fit within the native aortic valve, using its supra-annular valve position to help achieve excellent hemodynamic performance.

“We look forward to working with physicians across Europe to offer this highly anticipated valve size to the thousands of patients who were previously unable to receive TAVI due to valve size,” says Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, a part of Medtronic’s Cardiac and Vascular Group. “With this approval, the Evolut R platform now treats the broadest annulus range of any TAVI system on the market and expands the patient population that can now receive this life-saving therapy.”

The CoreValve Evolut R 34 mm valve received Food and Drug Administration (FDA) approval in the United States in October 2016 for severe aortic stenosis patients who are at high or extreme risk for surgery with an annulus size ranging from 26 to 30 mm.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

Related Articles Read More >

Logos of Creo Medical and Intuitive
Creo Medical inks collaboration agreement with Intuitive
Lazurite ArthroFree wireless surgical camera system Minnetronix Medical
How Minnetronix Medical helped Lazurite with its wireless surgical camera
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

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
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