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

Larger Transcatheter Aortic Valve Replacement Technology in Clinical Trial

June 15, 2016 By PinnacleHealth System

PinnacleHealth enrolled the first patient nationally in a new clinical trial investigating a larger size of the Medtronic CoreValve Evolut R system — the Evolut R 34mm. The larger transcatheter aortic valve replacement (TAVR) technology is designed to treat severe aortic stenosis patients with a larger base of the aortic root, called the annulus, specifically those with an annulus diameter between 26-30mm. Annulus sizes vary between individuals.

For many years, the gold standard treatment for severe aortic stenosis has been open surgery. Surgical aortic valve replacement (SAVR) allows the surgeon to clearly visualize and measure the annulus. With TAVR, physicians rely on advanced imaging technology to model the anatomy of the heart, measure the annulus and select the appropriate valve size. With both SAVR and TAVR, accurate sizing is one factor in long-term patient outcomes. TAVR procedures have been limited to patients with a smaller annulus, specifically a diameter less than 26 mm.

The 34mm valve replaces a diseased aortic heart valve through a minimally invasive procedure, without open-heart surgery and without surgical removal of the diseased valve. The device is typically inserted via an artery in the leg and then guided through the arteries into the heart. Once in place, the device expands and takes over the original valve’s function to enable oxygen-rich blood to flow efficiently out of the heart.

Aortic stenosis is a common heart problem caused by a narrowing of the heart’s aortic valve due to excessive calcium deposited on the valve leaflets.

When the valve narrows, it does not open or close properly, making the heart work harder to pump blood throughout the body. Eventually, this causes the heart to weaken and function poorly, which may lead to heart failure and increased risk for sudden cardiac death.

The new trial for the Evolut R 34mm System at PinnacleHealth is led by Mubashir Mumtaz, MD, FACS, FACC, chief of cardiothoracic surgery and surgical director of structural heart, and Hemal Gada, MD, MBA, medical director of structural heart.

The Medtronic U.S. clinical study is a prospective, single-arm study that will include 60 patients at up to 15 clinical sites. The study is designed to confirm the safety and efficacy of the CoreValve Evolut R 34mm system and to compare the results to the Evolut R IDE. The prospective study will have a primary safety endpoint of all-cause mortality or disabling stroke at 30 days and primary efficacy endpoints of device success and total regurgitation at 30 days.  

The Medtronic Evolut R 34mm builds off of the CoreValve Evolut R transcatheter valve, which was FDA-approved for commercial use in the U.S. in June 2015 for severe aortic stenosis patients who are at high or extreme risk for surgery.

The PinnacleHealth System provides inpatient and outpatient healthcare services in central Pennsylvania. The 636-bed system has three acute care hospitals on four campuses serving a five-county service area and supporting rural hospitals through affiliations and telehealth services.

Related Articles Read More >

iRhythm stays silent on federal grand jury subpoenas
iRhythm stock soars on Street-beating Q1
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Integer Holdings
Integer to exhibit at Heart Rhythm 2022

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