St. Jude Medical, Inc. has enrolled a first patient in the EnligHTN II trial. This post-market clinical study will further evaluate the safety and efficacy of the EnligHTN™ Renal Denervation System in patients with uncontrolled hypertension.
According to the World Health Organization (WHO), one in three adults worldwide has elevated blood pressure – a condition that increases the risk of heart attack, stroke and kidney failure.
Renal denervation as a therapeutic solution to high blood pressure has been the subject of quite extensive clinical trials already. To date however studies have only tested the safety and efficacy of the technology in patients with so-called drug-resistant hypertension, which is defined as systolic blood pressure above160 mmHg, despite being on three or more anti-hypertensive medications including a diuretic.
The EnligHTN II study aims to broaden this scope by evaluating the mean reduction in systolic blood pressure at six months across all enrolled patients post renal denervation and within sub-groups with varying degrees of kidney functionality. The study will be conducted at 40 sites in Europe and Australia and will enroll approximately 500 patients with uncontrolled hypertension.
“There is convincing evidence from studies like the EnligHTN I trial linking renal denervation to improved blood pressure in patients who have drug-resistant hypertension,” said Dr. Johannes Brachmann at Klinikum Coburg in Coburg, Germany. “Expanding this research to patients with less severe forms of hypertension is important as this minimally invasive approach allows for a shorter procedure time and a potentially faster recovery time, which may benefit more patients with uncontrolled hypertension.”
“St. Jude Medical is dedicated to conducting research that will contribute to the body of evidence supporting the effectiveness of renal denervation in reducing hypertension,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “Through the course of the EnligHTN II study, we expect to gain additional insights into the benefits and sustainability of blood pressure reductions achieved through use of the EnligHTN Renal Denervation System in an expanded patient population.”
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.
Source: St.Jude Medical, Inc., Business Wire