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|St. Jude Medical Initiates Landmark Study of Renal Denervation for Reduction of Heart Attack, Stroke and Death|
EnligHTNment trial will evaluate whether patients with hypertension that are treated with renal denervation and medication experience additional benefits beyond a reduction in blood pressure
Image of the St. Jude Medical EnligHTN(TM) Renal Denervation System. (
Uncontrolled hypertension occurs when blood pressure in the arteries
remains elevated, requiring the heart to work harder than normal to
circulate blood throughout the body. This condition puts one in three
adults worldwide at risk of heart attack, stroke and kidney failure
according to the
“To date, the renal denervation studies that have been conducted only
looked at reducing blood pressure in patients with uncontrolled or
resistant hypertension,” said Professor
Renal denervation therapy is a minimally invasive procedure that uses radiofrequency (RF) energy to disrupt the renal nerves, which lead in and out of the kidneys. The RF energy creates lesions (tiny scars) along the renal sympathetic nerves – a network of nerves that help control blood pressure. This intentional disruption of the nerve supply causes systolic and diastolic blood pressure to decrease.
“Initial study results have demonstrated that the EnligHTN Renal
Denervation System is safe and effective in rapidly lowering blood
pressure. If these results extend into the prevention of major cardiac
events, there is the potential to dramatically change how we treat these
patients,” said Professor
The EnligHTNment trial will be an international, multi-center, randomized, controlled study examining the safety and effectiveness of renal denervation with the EnligHTN™ Renal Denervation System in reducing risk of major cardiovascular events.
“We are committed to making the right investments to lead the emerging field of interventional treatment for hypertension,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “Like other landmark trials we have sponsored, this first-of-its kind study provides the opportunity to evaluate patient outcomes that matter the most – heart attack, stroke and death.”
About Renal Denervation and the EnligHTN System
Renal denervation is a catheter-based ablation procedure that potentially provides lasting reduction in blood pressure for patients with hypertension. A catheter is introduced through the femoral artery in the leg to access the renal arteries that connect to the kidneys. Once in place, the tip of the catheter is held against the surface of the artery where radiofrequency (RF) energy is delivered to the surrounding nerves.
The EnligHTN system is a multi-electrode ablation technology that features a unique, non-occlusive basket design that delivers a predictable pattern of four evenly-spaced ablations with each catheter placement. This allows for continuous blood flow to the kidney during the procedure. Compared to single-electrode ablation systems, the multi-electrode EnligHTN system has the potential to improve consistency and save time, which may result in improved workflow and cost efficiencies.
In 2012, the EnligHTN Renal Denervation System earned European CE Mark approval and was launched in several markets. It is not yet approved for use in the U.S.
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