Medtronic announces CE Mark and TGA listing for the Symplicity Spyral multi-electrode catheter and Symplicity G3 generator
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™ catheter and Symplicity G3™ 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™ 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.”