Study Says St.Jude’s EnligHTN Renal Denervation Technology Is Safe And Effective At Six Months

In short

St.Jude Medical’s EnligHTN™ renal denervation system was one subject of discussion at this year’s American Heart Association (AHA) meeting. Clinical follow up during the EnligHTN I study suggests the therapy provided a safe, effective and sustained blood pressure reduction six months after treatment.

Background

In the study, patients treated with the EnligHTN renal denervation system had to have treatment-resistant blood pressure and results suggested they averaged 176 / 96 mmHg. After treatment the group experienced an average rapid systolic blood pressure reduction of 28 mmHg points after 30 days which was sustained at 26 mmHg points after 6 months. 76% of patients responded to the therapy and had an average office blood pressure of 150 / 86 mmHg

Investigator comments

“Managing blood pressure is a critical factor in maintaining the overall cardiovascular health of patients with drug-resistant hypertension,” said Dr. Vasilios Papademetriou, clinical associate-scientific collaborator from First Cardiology Clinic at Hippokration Hospital in Athens, Greece, and a coordinating study investigator who presented the data at the AHA meeting. “These results are important as they show that use of the EnligHTN multi-electrode renal denervation system can rapidly and safely decrease blood pressure, and the reduction is sustainable over time.”

Company comments

“Renal denervation represents an important area of research in the management of hypertension for the millions of patients who live with this life-threatening condition,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “We are pleased with the rapid and sustained reduction of blood pressure to date and remain committed to advancing the science, technology and clinical evidence surrounding this important new procedure.”

Regulatory status

The EnligHTN Renal Denervation System earned European CE Mark approval and launched this year in several markets. It is not approved for use in the U.S.

Find more on the study and St.Jude’s EnligHTN system here.

Source: St.Jude Medical Inc., Business Wire