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News Release
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Mikhaila Ellis,
Public and Media Relations ,
+44 1923 212 213
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Medtronic Develops New Paediatric Oxygenator for Heart Surgery
First Worldwide Clinical Use in Great Ormond Street Hospital
LONDON – 1 July 2010 – Medtronic, Inc (NYSE: MDT), today announced that Great Ormond Street Hospital for Children NHS Trust, one of the most prestigious paediatric medical institutions in the world, has successfully used the new Affinity PixieTM paediatric oxygenator from Medtronic in its first clinical cases for infant and paediatric heart surgery. The Affinity Pixie oxygenator is a sophisticated oxygenation system used to add oxygen to the blood and remove carbon dioxide, essentially serving as the patient’s “lungs” while their heart is surgically corrected. Paediatric oxygenators are used in open heart surgery for correcting paediatric congenital heart disorders. These operations can typically be performed within 60 days of the baby's birth and some children may undergo several surgical procedures over a few years to correct their congenital heart disorder, due to the complexity of the disorder or as they grow. The Affinity Pixie Oxygenation System with BalanceTM Biosurface* gained CE Mark for clinical use throughout the European Union on 30th May 2010. It is not yet available in the United States for clinical use. The Affinity Pixie is designed for use with a broader range of patients and can be used to support approximately 75% of the neonate, infant and paediatric population undergoing cardiopulmonary bypass (it has a maximum flow rate of 2.0 L/min and a low prime volume of just 48 mL). The system also features the Affinity OrbitTM Holder System, which provides versatile device positioning and port orientation to aid reductions in circuit tubing length and associated prime volume. Additionally, it includes new design elements such as a hydrophilic biosurface without heparin (Balance Biosurface) to minimize the interaction of the patient's blood with foreign surfaces inside the device. This helps to preserve platelet function and so helps to preserve patient haemostasis (the ability of the blood to clot). Richard Crook, Deputy Chief Perfusionist at Great Ormond Street Hospital, who oversaw the first use of the oxygenator in surgery commented, “We’re very pleased to be able to use this new oxygenator. At Great Ormond Street Hospital, we pride ourselves on being an early implementer of new technology to help give the very best care to our patients. When you’re operating on babies and young children, improvements in medical equipment like this can make a vital difference. This new product provides a strong option for further optimisation of our Perfusion practice”. The Affinity Pixie oxygenator has been developed and manufactured in Minneapolis, Minnesota, USA by Medtronic, Inc. the global leader in the field of medical technology. Mark Rathbone, Medtronic UK & Ireland Cardiovascular Business Director, commented, “At Medtronic we are committed to ongoing innovation in medical technology. Each year Medtronic spends nearly 10 percent of global revenues on R&D. The Affinity NT oxygenator (for adult cardiopulmonary bypass), is used every 2 minutes, somewhere in the world. It is our intention to bring the Affinity Pixie Paediatric Oxygenation System to that same level of use, assisting young patients around the world.” The Affinity Pixie Oxygenation System is an additional step in a larger programme by Medtronic to develop a range of innovative new perfusion products to assist surgery for both for children and adults over the next few years. Medtronic is launching a “Commitment to Perfusion” campaign around the world, for more information please use the following link: www.perfusion.medtronic.com or to become part of the Perfusion Insider community go to: www.committedtoperfusion.com * Technology licensed under agreement from BioInteractions Limited, United Kingdom. Notes to Editors: At least 8 out of every 1000 babies born each year have a heart defect. About half of these babies have a minor defect and will not need any treatment but the rest need medical treatment or surgery. The majority of congenital heart defects are detected at birth. Symptoms of congenital heart defects can include: fast or difficult breathing: fatigue (tiredness); cyanosis (a bluish tint to the skin, lips, and fingernails); poor feeding and poor blood circulation. For more information please go to: http://congenital-heart-defects.co.uk or http://www.guch.org.uk 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. More information is available at: www.medtronic.co.uk 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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