First renal denervation with Medtronic Symplicity Catheter System performed in Latin America

Medtronic today announced the first use in Latin America of renal denervation with the Medtronic Symplicity Catheter System^™ to treat a patient with resistant hypertension, which is defined as high blood pressure despite treatment with three or more anti-hypertensive medications. Hypertension is an especially dangerous disease affecting hundreds of millions of people worldwide.

“Clinical research to date shows that renal denervation with the Symplicity Catheter System may provide a significant and sustained reduction in blood pressure levels for many patients with resistant blood pressure despite multiple anti-hypertensive medications. We are proud to introduce this innovative treatment option in Latin America.”

The first use of this minimally invasive, catheter-based procedure in Latin America occurred August 4, 2011 at Clinica Santa Maria in Santiago, Chile. It was a feature live case at the SOLACI Conference, the annual meeting of Latin American Interventional Cardiologists.

"We're excited to partner with hypertension specialists to offer this innovative interventional treatment to patients in our country," said Dr. Hernan Chamorro, the interventional cardiologist who performed the procedure. "Renal denervation is an exciting new approach to treating the resistant hypertension so prevalent in our country, and Clinica Santa Maria is proud to offer this new treatment option. Patients whose blood pressure remains uncontrolled face increased cardiovascular risk and may now benefit from this solution."

According to a study by Kearney et al. on the global burden of hypertension, the prevalence of hypertension in the Latin American population over 20 years of age sits above 40%. A large number of these hypertension patients may not achieve target blood pressure levels with first-line therapies.

The Symplicity Catheter System^™ accomplishes renal denervation, a minimally invasive procedure that disables sympathetic nerves located in the renal artery walls. The system consists of a generator and a flexible catheter. The catheter is introduced through the femoral artery in the upper thigh and is threaded up into the renal artery near each kidney. Once in place, the tip of the catheter delivers low-power radio-frequency (RF) energy according to a proprietary algorithm, or pattern, to affect the surrounding sympathetic nerves. The procedure does not involve a permanent implant.

Medtronic is leading the development of renal denervation therapy. Having received Europe's CE (Conformité Européene) mark and a listing with Australia's Therapeutic Goods Administration (TGA), the Symplicity Catheter System^™ is commercially available in Europe and Australia. The Symplicity Catheter System is under investigational use in the United States and is not approved for U.S. commercial sale.

James Hogan, president of Medtronic Latin America, traveled to Santiago to observe the first case, and commented: "Clinical research to date shows that renal denervation with the Symplicity Catheter System may provide a significant and sustained reduction in blood pressure levels for many patients with resistant blood pressure despite multiple anti-hypertensive medications. We are proud to introduce this innovative treatment option in Latin America."

Results from SYMPLICITY HTN-2, a randomized, controlled clinical trial of 106 patients in Europe, Australia and New Zealand, showed that patients with resistant hypertension randomized to renal denervation achieved a mean blood pressure reduction of 32/12 mmHg at 6 months, whereas the patients in the control group randomized to anti-hypertensive medications alone had blood pressures that did not vary from baseline (1/0 mmHg). The overall occurrence of adverse events did not differ between groups.

Hypertension is the leading attributable cause of death worldwide. It is a significant, escalating global healthcare problem affecting approximately 1.2 billion people and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death. Hypertension is estimated to have a direct cost to the global healthcare system of more than $500 billion annually. Although pharmaceutical therapy plays a primary role in hypertension management, drugs alone are sometimes not effective for all patients. As a result, despite lifestyle changes and the availability of anti-hypertensive agents, approximately 50 percent of patients with hypertension remain uncontrolled, and approximately 15-20 percent of those are resistant.

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.