December 6, 2013 — Medtronic Inc. announced CE mark in Europe and Therapeutic Goods Administration (TGA) listing in Australia for its flexible 4-French, 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 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 French catheter is compatible with a 6 French 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, M.D., Ph.D., 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.
Symplicity Clinical Trial Program
Medtronic’s clinical evaluation program of the Symplicity renal denervation system will involve more than 8,000 patients worldwide, including the United States, Europe and Japan, with more than 1,200 of these patients participating in randomized clinical trials.
- SYMPLICITY HTN-1: A series of pilot studies at 19 centers in Australia, Europe and the United States with 153 patients with systolic blood pressure ?160 mmHg enrolled. SYMPLICITY HTN-1 is the longest running clinical trial investigating the safety and efficacy of renal denervation.
- SYMPLICITY HTN-2: A randomized, controlled clinical trial of 106 patients at 24 centers in Europe, Australia and New Zealand to investigate renal denervation in patients with treatment-resistant hypertension randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment or to maintain previous treatment alone.
- SYMPLICITY HTN-3: First and only pivotal U.S. clinical trial of the Symplicity renal denervation system for uncontrolled hypertension completed enrollment of 535 patients across nearly 90 U.S. medical centers in May 2013. The results are expected to be available during the first half of 2014.
- SYMPLICITY HTN-4: First randomized, controlled trial to investigate renal denervation for moderate uncontrolled hypertension in U.S. patients with systolic blood pressure between 140 and 160 mmHg. Enrollment began in November 2013.
- Global SYMPLICITY Registry: Prospective, multi-center, open-label registry of 5,000 patients in 200-plus centers, designed to document the long-term safety and effectiveness of renal denervation in real-world patient populations, as well as gather data for other diseases characterized by elevated sympathetic drive.
- SYMPLICITY-HF: Clinical study designed to evaluate the safety and physiologic response to renal denervation with the Symplicity system in patients with chronic heart failure and renal impairment. The study will enroll approximately 40 adult subjects with chronic heart failure and renal impairment in Europe and Australia.
- Symplicity Spyral Catheter Feasibility Study: Prospective, single-arm, non-randomized clinical study of Medtronic’s multi-electrode catheter, which completed enrollment of 50 patients in Australia and New Zealand designed to evaluate acute procedure safety and change in office blood pressure from baseline at six months.
- HTN-Japan: Open-label study being conducted in approximately 100 patients in up to 18 centers in Japan, designed to randomize subjects one-to-one to renal denervation versus no denervation with both groups receiving fully tolerated doses of antihypertensive medications.
- SYMPLICITY HTN-India: Open-label study being conducted in approximately 40 patients across several centers in India, designed to evaluate the safety and efficacy of renal denervation in the local population.
For more information: www.medtronic.com