Medtronic Issues IDE to FDA for Randomized Clinical Trial for Uncontrolled Hypertension Patients with Systolic Blood Pressure Between 140-160mm Hg

Medtronic, Inc. (NYSE: MDT), announced todaythat the company has submitted an Investigational Device Exemption (IDE) tothe U.S. Food and Drug Administration (FDA) to study the Symplicity(TM) renaldenervation system for the treatment of uncontrolled hypertension in patientswith systolic blood pressure between 140-160 mm Hg despite treatment withthree or more anti-hypertensive medications of different classes. TheSymplicity renal denervation system currently is only available forinvestigational use in the United States.Symplicity HTN-4 is the next step in Medtronic's global renal denervationclinical program designed to carefully and progressively build the clinicalevidence platform for the treatment of hypertension. This is beingaccomplished through a series of trials, which include more than 250 patientsalready enrolled in the Symplicity HTN-1 and Symplicity HTN-2 studies, 530patients being enrolled in the Symplicity HTN-3 study, and 5,000 patientsbeing enrolled in the Global SYMPLICITY Registry. The robust SYMPLICITY globaldataset with planned follow-up to 5 years in most studies will be utilized toevaluate not only blood pressure reduction, but also long-term cardiovascularoutcomes from hypertension such as stroke, myocardial infarction, heartfailure and cardiovascular death. Medtronic's rigorous clinical evaluationprogram of the Symplicity renal denervation system includes more than 8,000patients worldwide, including studies in the U.S., China, and Japan, with over1,200 of these patients participating in randomized clinical trials.The Symplicity HTN-4 trial will be the company's second randomized clinicaltrial in the U.S., with a patient population in line with the Joint NationalCommittee on the Prevention, Detection, Evaluation and Treatment of High BloodPressure (JNC-7), the American Heart Association and the European Society ofHypertension definition of resistant hypertension. Symplicity HTN-4 buildsupon the Symplicity HTN-3 study, Medtronic's pivotal U.S. clinical trial ofthe Symplicity renal denervation system for the treatment-resistanthypertension with systolic blood pressure greater than 160 mm Hg. SymplicityHTN-3 is the only clinical trial to date to receive an IDE approval to studyrenal denervation in the U.S. Medtronic aims to begin enrolling patients inthe Symplicity HTN-4 trial in the second half of 2013, pending regulatoryapproval.The principal investigators of Symplicity HTN-4 are David Kandzari, M.D.,Director and Chief Scientific Officer, Interventional Cardiology andInterventional Cardiology Research, Piedmont Heart Institute, Atlanta, GA, andMichael Weber, M.D., Professor of Medicine, Division of CardiovascularMedicine, at the SUNY Downstate College of Medicine in Brooklyn, New York."Symplicity HTN-4 demonstrates Medtronic's commitment to providing randomizedsafety and efficacy data for renal denervation in a wide variety of patients,as well as help increase our understanding of the potential benefit of renaldenervation on patients with a less severe form of treatment-resistanthypertension," said Sean Salmon, Senior Vice President and President, Coronary& Renal Denervation, Medtronic. "We intend to continue to add to thesubstantial body of evidence Medtronic has generated to support the use ofrenal denervation in broader patient populations worldwide in conditionsassociated with hyperactive sympathetic nervous system drive, includinguncontrolled and treatment-resistant hypertension, and heart failure."Hypertension is a major and growing global public health concern. It affectsan estimated 30-40 percent of the adult population^1-3 and contributesdirectly to strokes, heart attacks, heart failure and cardiovascularmortality.^4^, ^5 Numerous studies have demonstrated the continuous andconsistent benefit in terms of risk reduction with controlling bloodpressure.^4-6 Despite the availability of numerous safe pharmacologicaltherapies, the percentage of hypertensive patients achieving blood pressurecontrol to guideline target blood pressure values remains low. In the United States, the control rate for hypertensive patients takingmedications is approximately 60 percent,^7 leaving many uncontrolledhypertension patients at an increased cardiovascular risk.  Many patients withuncontrolled hypertension meet the criteria for treatment resistanthypertension in that their systolic blood pressure is >= 140 mm Hg despitebeing on three or more anti-hypertensive medications. The risk inherent withpersistently high blood pressure in these patients warrants specialtherapeutic considerations.^8Renal denervation therapy is a minimally invasive, catheter-based procedurethat modulates the output of nerves that lie within the renal artery wall andlead into and out of the kidneys. The nerves passing to the kidneys are partof the sympathetic nervous system, which affects the major organs that areresponsible for regulating blood pressure: the brain, the heart, the kidneysand the blood vessels.The Symplicity system's catheter and proprietary generator and algorithms werecarefully and specifically developed through years of clinical experience toaccomplish the renal denervation procedure. The Symplicity renal denervationsystemwas launched commercially in April 2010 and is currently available inparts of Europe, Asia, Africa, Australia, Canada and Latin America and hasbeen used to treat thousands of patients with treatment-resistant hypertensionworldwide.The Symplicity renal denervation system consists of a flexible catheter andproprietary generator. In an endovascular procedure, similar to anangioplasty, the physician inserts the small, flexible Symplicity^(TM)catheter into the femoral artery in the upper thigh and threads it into bothrenal arteries in turn. Once the catheter tip is in place within the renalartery, the Symplicity^(TM) generator is activated to deliver a controlled,low-power radio-frequency (RF) energy routine according to a proprietaryalgorithm aiming to deactivate the surrounding renal nerves. This, in turn,reduces hyper-activation of the sympathetic nervous system, which is anestablished contributor to chronic hypertension. The procedure does notinvolve a permanent implant.The FDA granted Medtronic approval for the Symplicity HTN-3 study in August2011. More information about Symplicity HTN-3, which is currently enrollingpatients, can be found at www.symplifybptrial.com.