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.
