Medtronic MDT today announced the first U.S. implant
of the Evera MRI(TM) SureScan^® implantable cardioverter-defibrillator (ICD)
System, following U.S. Food and Drug Administration (FDA) approval for its
Investigational Device Exemption (IDE) application and pivotal clinical trial
protocol. Evera MRI is the first ICD system to be evaluated in the U.S. that
allows for magnetic resonance imaging (MRI) scans positioned on any region of
the body. The first device was successfully implanted at Marquette General
Hospital in Marquette, Mich., by Mark Cowan, M.D., as part of the Medtronic
randomized, global pivotal clinical trial that will enroll up to 275 patients
at approximately 45 centers. The Evera MRI ICD System is currently available
only for investigational use in the United States.
It is estimated that that as many as 63 percent of ICD patients will need an
MRI within 10 years of receiving a device.^[1] Because no ICD system has yet
been approved for MR-Conditional use in the U.S., patients with devices have
been contraindicated from receiving MRI scans; this is because of the
potential interactions between the MRI, ICD function and patient safety.
"ICD patients in the U.S. are frequently denied access to MRI, and results
from this clinical trial may give us the evidence needed to make MRI
standard," said Michael R. Gold, M.D., Ph.D., Michael E. Assay professor of
medicine and director of cardiology at the Medical University of South
Carolina, and principal investigator in the study. "We are optimistic about
the possibilities that may be ahead for ICD patients, many of whom will need
MRI scans during their lifetimes. Adding an ICD that would allow patients to
have full-body access to MRI would be a significant breakthrough for this
patient population."
Evera MRI is designed to better fit inside the body, with a contoured shape
and thin, smooth edges that increase patient comfort by reducing skin pressure
by 30 percent.^[2] The Evera MRI is designed to maintain the same
industry-leading battery longevity (up to 11 years) compared to previous
devices.^[3]^,^[4]^,^[5]^,^[6]^,^[7]^,^[8]^,^[9]^,^[10] In addition, patients
in the study implanted with Evera MRI will receive the Sprint Quattro^® Secure
family of ICD leads, which has 10 years of proven performance with active
monitoring^[11] and is designed to be safe in an MRI environment.^[12]
Evera MRI includes SmartShock(TM) 2.0 - an exclusive shock reduction algorithm
that is designed to enable the device to better differentiate between
dangerous and harmless heart rhythms. While the majority of shocks delivered
are necessary to treat potentially fatal arrhythmias, studies estimate that
approximately 20 percent of patients with implantable defibrillators may
experience inappropriate shocks in response to a benign arrhythmia or
electrical noise sensed by the device.^[13] SmartShock technology has shown to
help eliminate these inappropriate shocks, and delivers a 98-percent
inappropriate shock free rate at one year.^[14]^,^[15] Also included in the
Evera MRI is OptiVol^® 2.0 Fluid Status Monitoring and complete diagnostics,
which is designed to identify patients at risk of worsening heart failure and
atrial fibrillation.
"Our goal with the Evera MRI system is to give patients the most unrestricted
access to MRI scans, and ultimately allow them to get the diagnostic answers
they need," said Marshall Stanton, M.D., vice president and general manager of
the tachycardia business at Medtronic. "Medtronic has been a leader in
developing implantable devices that are safe for the MRI environment, and we
believe ICDs will be no exception in the near future."
The Evera MRI system is the latest addition to a growing number of Medtronic
devices which are designed for MRI access including the Medtronic SureScan®
pacing systems, neurostimulation systems for the management of chronic pain
and the SynchroMed® II programmable drug infusion system.
In collaboration with leading clinicians, researchers and scientists
worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias.
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