Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Abbott’s Minimally Invasive MitraClip® System for Mitral Regurgitation Demonstrates Positive Clinical and Quality-of-Life Results for Patients Too High Risk for Surgery

March 10, 2013 By PR Newswire

SAN FRANCISCO, March 10, 2013 /PRNewswire/ — Abbott (NYSE: ABT) today announced data from the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High Surgical Risk cohort evaluating the company’s first-in-class catheter-based MitraClip® System for the treatment of mitral regurgitation (MR).  Findings were presented today at the 62nd Annual Scientific Session of the American College of Cardiology in San Francisco.

Abbott’s MitraClip system, an investigational device in the United States, received CE Mark in 2008 and is commercially available in approximately 30 countries, with more than 8,000 patients treated to date. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together the leaflets of the mitral valve to allow the heart to more efficiently pump blood.    

The EVEREST II High Surgical Risk cohort included data from patients enrolled in the multi-center EVEREST II High Risk and REALISM continued access studies. Findings from 351 symptomatic U.S. patients deemed too high risk for open mitral valve surgery demonstrated:

  • A 30-day mortality rate significantly lower than expected for surgery (4.8 percent for patients treated with the MitraClip system versus 18.2 percent predicted surgical mortality, p<0.0001);
  • A low rate of adverse events, despite the high surgical risk profile of the patients
  • An implant success rate of 96 percent;
  • Acute reduction in MR to 2+ or less achieved in 86 percent of patients treated with the MitraClip device;
  • Clinically significant improvement in left ventricular size, significant improvements in NYHA Functional Class and SF-36 Quality of Life scores, and significantly reduced rates of hospitalization for heart failure (48 percent reduction from one year post-discharge compared to the year prior to treatment, p<0.0001).

“Patients with mitral regurgitation who are not candidates for mitral valve surgery due to risk of mortality have an unmet need for a treatment option that will reduce symptoms and improve the quality of their lives,” said D. Scott Lim , M.D., associate professor of Cardiovascular Medicine at the University of Virginia Health System in Charlottesville, Va. “The findings of the EVEREST II High Surgical Risk cohort suggest that treatment with the MitraClip device represents a new option that could allow these high-risk patients to return to activities they enjoy, and results in a reduction in hospitalizations for heart failure.”  

“These results add to the large and growing body of data that show that the first-in-class percutaneous MitraClip therapy can have positive results for high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation,” said Charles A. Simonton , M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “We look forward to the March 20 FDA Advisory Committee meeting to discuss the MitraClip system as a treatment option for this patient group in the United States.”

Related Articles Read More >

A photo of Capstan Medical's mitral valve implant, which uses nitinol.
Capstan Medical’s R&D head discusses the heart valve and robotics startup’s tech, engineering challenges and solutions, advice for others in medtech and how to join his team
An illustration of a neurosurgeon using a robotic endoscope to remove a brain tumor.
MDO Nitinol Innovation Special Report
A photo of Highridge Medical CEO Rebecca Whitney.
Highridge Medical is betting on this spine tech
A photo of the miniature Auxilium Biotechnologies implants made on the International Space Station.
Implants 3D-printed in space could enable nerve regeneration
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

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

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
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • 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 our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. 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
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe