Medtronic announced the first use of renal denervation with its Symplicity catheter system in Latin America. It was used in a patient with resistant hypertension despite treatment with three or more anti-hypertensive medications.
The first use of this minimally invasive, catheter-based procedure occurred on 4 August 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 Hernan Chamorro, 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 energy according to a proprietary algorithm, or pattern, to affect the surrounding sympathetic nerves. The procedure does not involve a permanent implant.
The Symplicity catheter system is commercially available in Europe and Australia and is under investigational use in the United States.
James Hogan, president of Medtronic Latin America, 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 randomised, controlled clinical trial of 106 patients in Europe, Australia and New Zealand, showed that patients with resistant hypertension randomised to renal denervation achieved a mean blood pressure reduction of 32/12mmHg at 6 months, whereas the patients in the control group randomised 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.