St. Jude Medical Announces 6-Month Data for EnligHTN Renal Denervation System

November 5, 2012—St. Jude Medical, Inc. (St. Paul, MN) announced the presentation of data showing that the company's EnligHTN renal denervation system provided a safe, effective, and sustained reduction in office and ambulatory blood pressure measurements at 6 months. Vasilios Papademetriou, MD, who serves as an EnligHTN I coordinating study investigator, presented the data during the Clinical Science and Special Reports Session at the annual American Heart Association scientific sessions in Los Angeles.

According to St. Jude Medical, patients enrolled in the EnligHTN I study had an average blood pressure of 176/96 mm Hg despite being treated with multiple medications to manage this condition. Those treated with the EnligHTN renal denervation system experienced an average rapid systolic blood pressure reduction of 28 mm Hg after 30 days.

At 6 months, an average systolic blood pressure reduction of 26 mm Hg was maintained; 76% of patients responded to the therapy and had an average office blood pressure of 150/86 mm Hg. There were no serious acute device- or therapy-related adverse events reported.

“Managing blood pressure is a critical factor in maintaining the overall cardiovascular health of patients with drug-resistant hypertension,” commented Dr. Papademetriou, who is with First Cardiology Clinic at Hippokration Hospital in Athens, Greece. “These results are important as they show that use of the EnligHTN multielectrode renal denervation system can rapidly and safely decrease blood pressure, and the reduction is sustainable over time.”

St. Jude Medical describes the EnligHTN I trial as a prospective, multicenter feasibility study that treated 46 patients whose blood pressure remained resistant despite being on three antihypertensive medications and a diuretic. To be considered for the study, patients were required to have a systolic blood pressure ≥ 160 mm Hg (or ≥ 150 mm Hg for patients with type 2 diabetes).

The EnligHTN device includes a guiding catheter, ablation catheter, and ablation generator. The generator uses a temperature-controlled algorithm to produce effective lesions and allows for minimal catheter repositioning that may result in a reduction of contrast and fluoroscopic exposure. The EnligHTN renal denervation system earned CE Mark approval and was launched this year in several markets. It is not approved for use in the United States, the company advised.