Six-Month Pooled Outcome Data from the Symplicity HTN-2 StudyThe Symplicity HTN-2 trial i is an international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with treatment-resistant hypertension. One hundred-six (106) patients were enrolled from 24 investigational sites. At baseline, the randomized treatment and control patients had similar high blood pressures: 178/97 mm Hg and 178/98 mm Hg, respectively, despite both receiving an average daily regimen of five antihypertensive medications. Patients in the control arm of the study were offered renal denervation following assessment of the trial’s primary endpoint at six months following randomization. Pre-randomization, all patients in the study had an office-based systolic blood pressure ≥160 mm Hg despite adherence to at least three antihypertensive medications given at optimal dosage. Mean change in systolic and diastolic blood pressure was -28/-10 mg Hg (n=84) from baseline (p<0.001) to six months post-treatment. Renal function measures were unchanged (eGFR: 82.1±20.2 vs. 80.5±18.9mL/min/1.73m2; p=NS). There was one right artery dissection in a crossover patient, which occurred while injecting contrast during angiography. No other serious procedure-related adverse events occurred. ABOUT TREATMENT-RESISTANT HYPERTENSION Treatment-resistant hypertension, defined as persistently high blood pressure despite three or more anti-hypertensive medications of different types including a diuretic, puts approximately 120 million people worldwide at risk of premature death from kidney disease and cardiovascular events such as stroke, heart attack and heart failure. Research suggests that nearly one third of treated hypertensive individuals are considered resistant to treatment. ii Additionally, these patients have a three-fold increase in risk of cardiovascular events compared to individuals with controlled high blood pressure. iii ABOUT THE SYMPLICITY™ RENAL DENERVATION SYSTEM The Symplicity™ renal denervation system was launched commercially in April 2010 and is currently available in parts of Europe, Asia, Africa, Australia and the Americas. The Symplicity renal denervation system is not approved by the U.S. Food and Drug Administration (FDA) for commercial distribution in the United States. The Symplicity renal denervation system consists of a flexible catheter and proprietary generator. In an endovascular procedure, similar to an angioplasty, the physician inserts the small, flexible Symplicity™ catheter into the femoral artery in the upper thigh and threads it into the renal artery. Once the catheter tip is in place within the renal artery, the Symplicity™ generator is activated to deliver a controlled, low-power radio-frequency (RF) energy routine according to a proprietary algorithm, or pattern, aiming to deactivate the surrounding renal nerves. This, in turn, reduces hyper-activation of the sympathetic nervous system, which is an established contributor to chronic hypertension. The procedure does not involve a permanent implant.
The FDA granted Medtronic approval for the protocol for SYMPLICITY HTN-3, the company’s U.S. clinical trial of the Symplicity renal denervation system for treatment resistant hypertension in August 2011. SYMPLICITY HTN-3 is a randomized controlled trial designed to evaluate the safety and effectiveness of renal denervation with the Symplicity renal denervation system in patients with treatment-resistant hypertension. The study will include approximately 530 treatment-resistant hypertension patients across up to 90 U.S. medical centers. More information about HTN-3 can be found at www.symplifybptrial.com.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. 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. 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. i Symplicity HTN-2 Investigators. “Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomized, controlled trial.” The Lancet (2010) 376: 1093-1909. ii Egan, Brent M., et al. “Uncontrolled and Apparent Treatment Resistant Hypertension in the United States, 1988-2008.” Circulation 124. 9 (2011): 1046-1058. iii Doumas, Michael, et al. “Benefits from Treatment and Control of Patients with Resistant Hypertension.” International Journal of Hypertension 2011 (2011) Article ID 318549, 8 pages, 2011. doi:10.4061/2011/318549. Symplicity is a trademark of Medtronic Inc. and is registered in one or more countries of the world.