|Medtronic Announces CE Mark and TGA Listing for the Symplicity Spyral(TM) Multi-Electrode Catheter and Symplicity G3(TM) Generator|
Multi-Electrode System Built Upon Clinical Success and Strong Safety Profile of Single-Electrode Symplicity(TM) Renal Denervation System
MINNEAPOLIS -- December 5, 2013 -- Medtronic, Inc. (NYSE: MDT), announced today CE Mark (Conformité Européenne) in Europe and Therapeutic Goods Administration (TGA) listing in Australia for its highly flexible 4 Fr multi-electrode Symplicity Spyral(TM) catheter and Symplicity G3(TM) radio frequency (RF) generator. This new system is designed to significantly reduce ablation time and provide ease of deliverability during renal denervation procedures for patients with uncontrolled hypertension. The multi-electrode Spyral system leverages the proprietary Symplicity treatment algorithm and Symplicity helical ablation pattern responsible for the clinical success and unmatched safety profile of the single-electrode Symplicity renal denervation system. The Symplicity renal denervation system is available for investigational use only in the United States.
The Symplicity Spyral catheter features four electrodes that are able to deliver simultaneous or selective RF energy into the renal artery wall to disrupt the output of overactive sympathetic nerves. The new 4 Fr catheter is compatible with a 6 Fr guide catheter and is delivered over a 0.014 inch guide wire via a rapid exchange system. The Symplicity Spyral catheter is highly conformable to artery shape and size and accommodates vessel diameters of 3-8 mm. Its non-occlusive design ensures the catheter will not obstruct renal blood flow during the procedure.
"The multi-electrode Symplicity system builds upon the single-electrode Symplicity system by helping significantly reduce ablation time," said Michael Böhm, MD, PhD, Chairman, Department of Internal Medicine, University of Saarland, Homburg/Saar, Germany. "Further, the ease of use and exceptional deliverability help simplify the procedure."
The Symplicity Spyral catheter is powered by a new RF generator that leverages the benefits of Medtronic's proprietary Symplicity(TM) treatment algorithm with its built-in safety features. The system uniquely offers physicians control and flexibility with the ability to turn specific electrodes on and off to accommodate different anatomies. The G3 generator includes a new touch screen user interface compatible with the single-electrode Symplicity catheter.
"As we continue to drive the future of renal denervation as a treatment for uncontrolled hypertension, we are excited to deliver our fast and efficient multi-electrode Symplicity Spyral system, inspired by years of clinical experience and collaboration with top thought leaders in the field," said Nina Goodheart, Vice President, General Manager, Renal Denervation, Medtronic. "We have significantly enhanced our technology with sophisticated features designed to meet specific unmet needs and we believe these improvements, coupled with our strong safety and efficacy profile, will provide unprecedented benefit to both patients and physicians."
About Uncontrolled Hypertension
About the Symplicity Clinical Trial Program
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.
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.
- end -
Symplicity is a trademark of Medtronic Inc. and is registered in one or more countries of the world.
 Egan, Brent M., et al. "Uncontrolled and Apparent Treatment resistant Hypertension in the United States, 1988-2008." Circulation 124. 9 (2011): 1046-1058.
 Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, Jr., Jones DW, Materson BJ, Oparil S, Wright JT, Jr., Roccella E, Joint National Committee on Prevention DE, Treatment of High Blood Pressure. National Heart L, Blood I, National High Blood Pressure Education Program Coordinating C. Seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension. 2003;42:1206----1252.
 Staessen JA, Li Y, Thijs L, Wang JG. Blood pressure reduction and cardiovascular prevention: An update including the 2003----2004 secondary prevention trials. Hypertension research: official journal of the Japanese Society of Hypertension. 2005;28:385----407