Ardian

Results from Landmark Randomized Clinical Trial of Ardians Catheter-Based Treatment for Hypertension To Be Presented at American Heart Association Scientific Sessions 2010

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Ardian, Inc., a pioneer in catheter-based therapies for hypertension and related conditions, today announced that results from the company’s Symplicity HTN-2 trial will be the subject of a late breaking clinical trial presentation this week at the American Heart Association Scientific Sessions 2010 in Chicago, Ill.

The prospective, randomized, controlled Symplicity HTN-2 trial evaluated the safety and effectiveness of renal denervation with Ardian’s Symplicity® Catheter System™ vs. standard medical therapy in patients with uncontrolled hypertension. The study randomized 106 patients from 24 investigational sites in Europe, Australia and New Zealand. At baseline, the randomized treatment and control patients had similar high blood pressures: 178/97 mmHg and 178/98 mmHg, respectively, despite both receiving an average daily regimen of five antihypertensive medications.

The primary endpoint of the study is blood pressure reduction at six months. Kidney function, vascular safety and additional efficacy measures are also assessed.

Results will be presented on Wednesday, Nov. 17, 2010 at 11:51 a.m. CT by Prof. Murray Esler, associate director of the Baker IDI Heart and Diabetes Institute of Melbourne, Australia, the principal investigator of the Symplicity HTN-2 trial. A press conference will take place Wednesday, Nov. 17 at 8:00 a.m. CT. The press conference will be streamed live from MedPageToday.com.

About the Symplicity® Catheter System™

The Symplicity Catheter System is used to perform a procedure termed renal denervation (RDN). In a straight-forward 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 in place within the renal artery, the device delivers low-power RF energy to deactivate the surrounding renal sympathetic nerves. This, in turn, reduces hyper-activation of the sympathetic nervous system, which is often the cause of chronic hypertension. The one-time procedure aims to permanently reduce blood pressure. RDN may also allow patients to reduce or eliminate the need for lifelong antihypertensive medications.

In addition to hypertension, the therapy may hold promise for treating heart failure, diabetes and chronic kidney disease, conditions also characterized by elevated sympathetic nerve activity. The Symplicity Catheter System has received CE Mark approval in the European Union and is investigational in the United States. Visit http://www.ardian.com/patients/symplicity.shtml to view an animation of the device and the procedure.

About Hypertension

Though it has no symptoms, hypertension (high blood pressure) is the number one risk factor for premature death worldwide, affecting about one in three adults.1 Nearly half of Europeans suffer from hypertension2 and in the United States, approximately 75 million people are affected, only two-thirds of whom are treated.3 Of those receiving treatment, approximately half are not achieving target blood pressure levels. The medications often prescribed for hypertension must be taken daily for the duration of a patient’s life, can be costly, and often result in side effects that can negatively impact quality of life. Globally, the estimated annual healthcare expenditure directly related to hypertension is approximately $500 billion.4

About Ardian

Privately held Ardian Inc., based in Mountain View, Calif., develops catheter-based therapies to treat hypertension and related conditions. Ardian is the eighth company created by The Foundry, a leading medical device incubator based in Menlo Park, Calif. Ardian’s investors include Morgenthaler Ventures, Advanced Technology Ventures, Split Rock Partners, Medtronic and Emergent Medical Partners. For more information, please visit www.ardian.com.

1 Mathers, C., et al. World Health Organization; 2009.
2 Wolf-Maier, K., et al. JAMA 2003;289:2363-9.
3 Lloyd-Jones, D., et al. Circulation 2010;121;e46-e215.
4 Lawes, CM., et al. Lancet. 2008;371:1513-1518.