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

Mitralign Completes Enrollment in EU Study for its Novel Catheter-based Valve Repair Device

April 8, 2014 By the Associated Press

Mitralign Inc., a cardiac device company, announced today it has completed enrollment in a study in Europe investigating its lead device, the Mitralign System, in patients with functional mitral regurgitation (FMR). Pending successful outcomes from the study, the company will seek CE Mark approval in the European Union (EU) as a first step toward commercializing the Mitralign System. Receiving the CE Mark demonstrates that a product has been assessed by the European Commission for Enterprise and Industry and meets EU safety, health and environmental protection requirements.

“This is an important milestone for our company and brings our Mitralign System that much closer to patients who suffer this severe heart disease,” said Rick Geoffrion, chief executive officer of Mitralign. “We have completed the enrollment of 61 FMR patients in Europe, and we are in the process of collecting the necessary follow-up data for submission to our notified body in Europe for CE Mark approval. In the meantime, we will continue to enroll patients within our active clinical studies in order to accrue additional data for the medical community. We expect to report results from this trial before the end of 2014.” FMR is a condition brought on by a single or series of ischemic events, such as a heart attack or by the onset of cardiomyopathy. Patients with FMR often see a progressive enlargement of the heart, stretching open the mitral valve to allow the backflow of blood within the heart, thereby exacerbating the deterioration of heart function.

The Mitralign System utilizes a system of wires and catheters to implant at least one pair of polyester anchors within the mitral annulus, a ring of tissue surrounding the mitral valve. The anchors are then cinched together, reducing the circumference of the mitral valve towards its normal size with a goal to improve heart function and assist in the alleviation of heart failure symptoms.

“Patients with FMR are very sick and often experience a dilation of the heart and the deterioration of heart function, despite optimal medical therapy,” said Georg Nickenig, M.D., Mitralign’s lead investigator and professor at the Universitätsklinikum Bonn in Germany. “It is our hope that this novel device will provide a therapeutic option for these patients and improve their quality of life.”

Related Articles Read More >

Medtronic HeartWare HVAD
Another Medtronic HVAD recall is serious
A cylindrical-shaped medical device with a blue cap on one end and a brown cap on the other
How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
FDA logo
FDA seeking innovations to move beyond heater-cooler device problems
A Medtronic HVAD pump opened up to show the inner workings
FDA designates new Medtronic HVAD pump implant recall as Class I

DeviceTalks Weekly.

June 24, 2022
How innovative design, commercial strategy is building Cala Trio’s bioelectronic medicine market
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. 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
    • 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