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New Data from St. Jude Medical Study of EnligHTN Renal Denervation System Presented Today at Scientific Symposium

Press releases may be edited for formatting or style | October 29, 2013

"St. Jude Medical has invested in a robust clinical program to build the body of clinical evidence intended to support renal denervation as the standard of care for the treatment of drug-resistant hypertension," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. "These new data from our first renal denervation study demonstrate this therapy is durable and can benefit patients struggling to control their hypertension."

Renal Denervation and the EnligHTN System

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The EnligHTN system is a multi-electrode ablation technology for renal denervation, a minimally invasive procedure to treat patients with drug-resistant hypertension. The system delivers a series of radiofrequency (RF) energy ablations to create lesions (tiny scars) along the renal sympathetic nerves - a network of nerves leading to the kidneys that help control blood pressure. A normal blood pressure is typically at or below 120 systolic and 80 diastolic, which is expressed as 120 / 80 mmHg. Hypertension is categorized as a blood pressure reading greater than 140 / 90 mmHg. The risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure.

Compared to single-electrode ablation systems, the non-occlusive basket design of the multi-electrode EnligHTN system has the potential to improve procedural accuracy, save time as well as result in workflow and cost efficiencies. This also allows for continuous blood flow to the kidney during the procedure.

In May 2012, the first-generation EnligHTN Multi-Electrode Renal Denervation System earned European CE Mark approval and was launched in several markets. The company also announced CE Mark approval of the next-generation EnligHTN system in August 2013. Featuring an advanced generator, the next-generation system delivers simultaneous ablations via the multi-electrode catheter, reducing total ablation time by more than 80 percent, from approximately 24 minutes to four minutes. The EnligHTN systems are not yet approved for use in the U.S.

St. Jude Medical is conducting multiple renal denervation studies to add to the body of evidence supporting the potential of renal denervation therapy. In June 2013, the company announced the FDA approval to start a U.S. clinical trial, EnligHTN IV, evaluating the use of the EnligHTN Multi-Electrode Renal Denervation System to treat 590 patients at up to 80 sites across the U.S. and Canada with drug-resistant high blood pressure. The EnligHTN IV trial is now enrolling patients in the U.S.

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