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Perfusion NewswireMain ZoneMEDTRONIC ANNOUNCES FDA CLEARANCE AND FIRST USES OF NEW OXYGENATION SYSTEM FOR ADULT CARDIAC SURGERY

MEDTRONIC ANNOUNCES FDA CLEARANCE AND FIRST USES OF NEW OXYGENATION SYSTEM FOR ADULT CARDIAC SURGERY

MINNEAPOLIS – April 2, 2013 – Medtronic, Inc. (NYSE: MDT)
today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and
the first U.S. clinical uses of its new Affinity Fusion® oxygenation system.
This system, which is designed to serve as a patient’s lungs by oxygenating and
removing carbon dioxide from blood during various open-heart surgical
procedures, incorporates numerous innovations for patient safety and ease of
use. Notably, system enhancements are designed to prevent and remove air
bubbles that can enter the blood during the procedure, which may potentially
reduce the risk of stroke.

 

The Affinity Fusion oxygenation system’s new design
enhancements include:

•             A
proprietary fiber winding process with an interlaced pattern that efficiently
filters the blood and removes particles and air while at the same time
oxygenating the blood;

•             Smooth
tubular pathways for blood to pass through and a first-of-its-kind curved
venous inlet tube, both of which can reduce blood turbulence during the
surgical procedure;

•             Enhanced
setup and customization capabilities, including a new oxygenator system holder,
which gives perfusionists improved flexibility and ease of use in various
operating rooms, including those with limited space. 

 

“The new Affinity Fusion oxygenator is designed to
provide perfusionists with the most innovative and enhanced product of its
kind,” said cardiac surgeon Dr. John Liddicoat, senior vice president and
president of Medtronic’s Structural Heart division. “With so many patients
undergoing cardiac surgery each year, Affinity Fusion provides patients with a
reliable oxygenation system that is designed to proactively manage air and
gently handle blood.  This is an
important consideration for hospitals that are focused on implementing patient
blood management programs and other initiatives that can impact costs
associated with transfusions and post-operative complications.”

 

The Fusion oxygenation system was used in the U.S. for
the first time at Cleveland Clinic by perfusionist Patrick Grady, director of
Perfusion Services and a paid member of the expert advisory board for the
Fusion, during an open-heart surgery in which a patient underwent a right
mini-thoracotomy and mitral valve repair procedure. The surgery was performed
by Joseph Sabik, M.D., chair of the Department of Thoracic and Cardiovascular
Surgery at Cleveland Clinic and a paid member of Medtronic’s valve scientific
advisory board. Additionally, the Fusion system was used in mitral valve repair
cases at The Heart Hospital Baylor Plano, in Plano, Texas by cardiovascular
surgeons Will Ryan, M.D., and Robert Smith, M.D., with chief perfusionist Al
Lione.  

 

The Fusion oxygenation system is used by perfusionists
during open-heart surgical procedures that require a bloodless, motionless
surgical field, such as lifesaving cardiopulmonary bypass surgery. As temporary
“lungs,” the system adds oxygen and removes carbon dioxide from the blood.  This year, cardiopulmonary bypass will occur
in roughly 1 million patients worldwide[i]. The development process of the
Fusion oxygenator included extensive collaboration between Medtronic engineers
and more than 500 perfusionists worldwide.

 

The Affinity Fusion oxygenator received CE Mark in
September 2012.

 

In collaboration with leading clinicians, researchers and
scientists, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias. The company strives to offer products and
services that deliver clinical and economic value to healthcare consumers and providers
worldwide.

 

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.

 

Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic’s periodic reports on file
with the Securities and Exchange Commission. Actual results may differ
materially from anticipated results.


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