Medtronic makes small waves: company releases mini

cardiac monitor, implants tiny transcatheter pacing system.

In this case, smaller is definitely better. Minneapolis,Minn.-based Medtronic Inc. has gained 510(k)
clearance from the U.S.Food and Drug Administration (FDA) and the CE mark for its Reveal
Linqinsertable cardiac monitor (ICM) system. With these clearances,Medtronic commences the
global launch of the tiny ICM which isapproximately a third of the size of an AAA battery.
Medtronic claims the monitor allows physicians to continuously and wirelessly monitor a patient's
heart for up to three years, with 20 percent more data memory than its larger predecessor, Reveal
XT.

In addition to its continuous and wireless monitoring capabilities, the system provides remote
monitoring through the Carelink Network, which allows physicians to request notifications to alert
them if their patients have had cardiac events. The Reveal Linq ICM is indicated for patients who
experience symptoms such as dizziness, palpitation, syncope (fainting) and chest pain that may
suggest a cardiac arrhythmia, and for patients at increased risk for cardiac arrhythmias.
"The Reveal Linq ICM monitor can help patients find answers to problems that may be heart-related
without interrupting their lifestyle," said Rod Passman, M.D., professor and associate director of
cardiac electrophysiology at the Northwestern University Feinberg School of Medicine in Chicago,
111. "The simplified procedure and insertion tools make the device faster and easier for physicians
to implant, which may expand access to more patients needing long-term monitoring."
Placed just beneath the skin through a small incision of less than1 centimeter in the upper left side
of the chest, the Reveal Linq ICMreportedly is often nearly invisible to the naked eye once inserted.
Thedevice is placed using a rrdnirnally invasive insertion procedure, hopedto simplify the experience
for both physicians and patients. The RevealLinq ICM is magnetic resonance-conditional, allowing
patients to undergomagnetic resonance imaging (MRI) if needed.
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"This miniaturized monitoring system is the result of many years of product development Mini
Implants Summit work from engineers focused on shrinking the size of medical devices while
maintaining their power and improving benefits for patients," said Pat Mackin, president
of Medtronic's Cardiac Rhythm Disease Management (CRDM) business and senior vice president.
"This is game-changing technology for patients who need cardiac monitoring."
The Reveal Linq system also includes the new Mycarelink patient monitor, a simplified remote
monitoring system with global cellular technology that transmits patients' cardiac device diagnostic
data to their clinicians from nearly any location in the world.
"This is a technology that is going to help us reach more patients at risk for cardiac arrhythmias and
help healthcare systems more efficiently manage difficult patient populations," said
Randy Lieberman, M.D., director of electrophysiology at Detroit Medical Center.
Following the Reveal Linq launch, Medtronic also announced the first U.S. implant of the equally

small Miera transcatheter pacing system (TPS).The device successfully was implanted at New
York University Langone Medical Center by Larry Chinitz, M.D., director of the university's Heart
Rhythm Center, as part of the Medtronic global pivotal clinical trial. The Miera TPS is an
investigational device worldwide.
At one-tenth the size of a conventional pacemaker and comparable in size to a large vitamin, the
Miera TPS is delivered directly into the heart through a catheter inserted in the femoral vein. Once
positioned, the pacemaker is attached to the heart wall and can be repositioned or retrieved if
needed. The miniature device does not require the use of wires, known as "leads," to connect to the
heart. Attached to the heart via small tines, the pacemaker delivers electrical impulses that pace
the heart through an electrode at the end of the device.
"With its small size and minimally invasive procedure, thistechnology represents the future of
pacing," said Chinitz."Eliminating the need for a lead and pocket has the potential toreduce
complications and recovery times compared to traditionalpacemaker implants, which would be a
major benefit to patients."
In contrast to current pacemaker implant procedures, the Miera TPS implant does not require a
surgical incision in the chest or the creation of a "pocket" under the skin. This eliminates
a potential source of device-related complications, and any visible sign of the device.
"Miera TPS is an example of the investment we have made in disruptive technology, specifically the
miniaturization of implantable cardiac devices," Mackin said. "Less invasive, miniature device
technologies show strong promise in improving patient outcomes and implant procedure efficiency.
The FDA's interactive review with CRDM was a key part of the [investigational device
exemption] application approval process, and through our global Miera TPS clinical trial, we intend
to generate evidence of these benefits to patients and clinicians throughout the world."
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The Miera TPS study is a single-arm, multi-center global clinical trial that will enroll up to 780
patients at approximately 50 centers. Initial results from the first 60 patients, followed up to three
months, are expected in the second half of 2014.