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 Receives CE Mark for Pacemaker Lead That Will Expand Patient Access to MRI Technology

March 6, 2012 By AxoGen, Inc.

MINNEAPOLIS–(BUSINESS
WIRE
)–Medtronic, Inc. today announced the receipt of CE Mark
(Conformité Européenne) and launch of the CapSure Sense MRI™ SureScan® pacing
leads, which are approved for use during Magnetic Resonance Imaging (MRI).
Medtronic introduced the first MR-Conditional pacemaker system in the world in
2008 and in the U.S.
in 2011.

The newly approved leads are the smallest MR–Conditional
leads available in the world. As passive-fixation leads (which attach to the
heart with small tines), they will give physicians an additional option that is
MR-Conditional, or designed to be safe for the MRI environment when used per
the specified MR Conditions for Use.i Previously approved Medtronic
MR–Conditional leads are active fixation leads, which fasten directly into the
cardiac tissue.

With approximately 60 million MRI procedures performed
worldwide each year,ii there has been increasing demand for MR–Conditional
pacing systems. MRI procedures are indicated for 17 percent of pacemaker
patients within 12 months of device implant.iii

“The CapSure Sense MRI SureScan® leads address an unmet
clinical need for thoroughly tested MRI conditional passive fixation
leads,” said Gianluca Botto, M.D., director of EPS Unit at St.
Anna Hospital
in Como, Italy. “With this new lead, there
is now a full portfolio of options available for physicians and their patients,
when this lead is combined with an MR–Conditional device.”

To assure the safety of patients and the effectiveness of
the patients pacing therapy, the CapSure Sense MRI leads were tested in more
than 400,000 scenarios that evaluated different patient body types, scanning
locations, MRI scanner types and lead lengths.

“Now patients and physicians will have access to MRI passive
leads approved for full body MRI scans,” said Pat Mackin, president of the
Cardiac Rhythm Disease Management business and senior vice president at
Medtronic. “This is a major step forward in addressing both patient access and
providing physician options.”

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical
technology – alleviating pain, restoring health, and extending life for
millions of people around the world.

i Wilkoff B, et al. Magnetic resonance imaging in patients
with a pacemaker system designed for the magnetic resonance environment. Heart
Rhythm 2011; 8(1): 65-73.

ii Sutton R, Kanal E, Wilkoff BL, Bello D, et al. Safety of
magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI
SureScan pacing system: clinical study design. Trials 2008, 9:68

iii Sommer T, Naehle CP, Yang A, Zeijlemaker V, et al. Strategy
for safe performance of extrathoracic magnetic resonance imaging at 1.5 Tesla
in the presence of cardiac pacemakers in non–pacemaker-dependent patients: A
prospective study with 115 examinations. Circulation, Sep 2006; 114: 1285 –
1292.

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies

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