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|Medtronic Reports Strong Safety and Sustained Clinical Efficacy Results of the Symplicity(TM) Renal Denervation System from the Global SYMPLICITY Registry|
Six and 12-Month Data from Largest Real-World Patient Population
MINNEAPOLIS and AMSTERDAM - September 2, 2013 - Medtronic, Inc. (NYSE: MDT), announced today at the European Society of Cardiology (ESC) Congress, new data from the Global SYMPLICITY Registry that continue to affirm the strong safety profile of the Symplicity(TM) renal denervation system in a real-world patient population. Among the 1,158 patients analyzed in the registry with follow-up information available for this analysis, major complications or serious adverse events related to delivery of radio frequency (RF) energy to the renal artery were rare, including one procedural dissection (0.09 percent) and one re-intervention at 6 months (0.09 percent).
The primary goal of the Global SYMPLICITY Registry is to confirm procedural safety with the Symplicity system. Available data for the secondary efficacy analysis showed significant and sustained blood pressure reductions after renal denervation with the Symplicity system at all time points up to 12 months in both in-office and ambulatory blood pressure measurement, compared to baseline. The Symplicity renal denervation system is available for investigational use only in the United States.
"It is encouraging that preliminary data with this sizeable patient cohort in a real-world setting continue to demonstrate a strong safety profile and significant clinical efficacy for renal denervation with the Symplicity system, similar to what we've been seeing in the randomized, controlled clinical trial, Symplicity HTN-2," said Michael Böhm, MD, PhD, Chairman, Department of Internal Medicine, University of Saarland, Homburg/Saar, Germany and Global SYMPLICITY Registry co-chair.
Data presented by Prof. Böhm during an oral session at ESC 2013 in Amsterdam on Tuesday, September 2, 2013 reported patients with systolic blood pressure of >=180 mm Hg at baseline (n=51) had an average in-office blood pressure reduction of -29/-17 mm Hg from baseline at six months [p<0.001] and -37/-23mm Hg from baseline at 12 months (n=9) [p=0.001 SBP/p=0.0005 DBP]. Patients with similar characteristics to the Symplicity HTN-2 trial, with a systolic blood pressure of ³160 mm Hg (or >=150 mm Hg in patients with diabetes) had an average in-office blood pressure reduction of -19/-8 mm Hg from baseline at six months (n=313) [p<0.001] and -22/-11 mm Hg from baseline at 12 months (n=79) [p<0.001]. Average reductions in available ambulatory blood pressure measurements were -10/-5mm Hg from baseline to six months (n=132) [p<0.0001].
The Global SYMPLICITY Registry is a multi-center, prospective, observational registry designed to collect comprehensive data evaluating procedural and long-term safety of the Symplicity system, clinical efficacy for both in-office and ambulatory blood pressure measurement, and long-term cardiovascular outcomes from hypertension such as stroke, myocardial infarction, heart failure and cardiovascular death. More than two thirds (66%) of registry patients treated to date fall within current ESC consensus paper recommendations for catheter-based renal denervation, including a systolic blood pressure of >= 160 mm Hg (>= 150 mmHg Diabetes II) and were taking at least three classes of anti-hypertensive medications, including diuretic, prior to treatment with renal denervation.1
"We are pleased that enrollment and analysis of the registry continues to meet our goal of establishing procedural safety and efficacy of the Symplicity system, which we expect will ultimately help reduce the risk of cardiovascular events associated with treatment-resistant hypertension such as stroke and ischemic heart disease," said Dr. Bohm.
As the largest renal denervation registry in the world to date and the first-of-its-kind to evaluate this novel treatment in a real-world, uncontrolled population, The Global SYMPLICITY Registry will enroll more than 5,000 patients in a minimum of 200 centers with planned follow-up to five years. The registry also will gather data for other diseases characterized by elevated sympathetic drive, such as diabetes mellitus type 2, heart failure and chronic kidney disease.
With the continued success of the Global SYMPLICITY Registry, Medtronic strengthens its position as the global leader in the research and development of renal denervation therapies. Ultimately, Medtronic's global Symplicity clinical program will involve more than 8,000 patients worldwide.
About the Symplicity Clinical Trial Program
About the Symplicity(TM) Renal Denervation System
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.
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Symplicity is a trademark of Medtronic Inc. and is registered in one or more countries of the world.
1 Mahfoud F et al. Expert consensus document from the European Society of Cardiology on catheter-based renal denervation, Eur Heart J April 2013