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ACI performs first procedure of novel treatment for high blood pressure - Advanced Cardiovascular Institute. Complete Cardiovascular Care Solutions.

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Home » News » ACI performs first procedure of novel treatment for high blood pressure

ACI performs first procedure of novel treatment for high blood pressure

Advanced Cardiovascular Institute (ACI) today became the first medical facility in the Caribbean to use 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.

Advanced Cardiovascular Institute joins a small but growing number of institutions in the Western hemisphere to offer this minimally invasive, catheter-based procedure. Patients whose blood pressure remains uncontrolled face increased cardiovascular risk. Cardiovascular disease is the main cause of death worldwide.

A 41 year old, female, of south Trinidad was the first patient at Advanced Cardiovascular Institute to have the procedure.

“We’re excited to partner with hypertension specialists to offer this interventional treatment to our patients, which represents a new and innovative approach to treating resistant hypertension,” said Dr. Ronald Henry, ACI Medical Director. “Renal denervation and ongoing treatment with anti-hypertensive medications provides resistant hypertension patients the opportunity to achieve target blood pressure levels.”

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.

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.

The Symplicity Catheter System™ has received the CE (Conformité Européene) mark and Australia’s Therapeutic Goods Administration (TGA) listing and is commercially available in Europe and Australia. The Symplicity Catheter System is under investigational use in the United States and is not approved by the FDA for U.S. commercial sale.

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. 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.