St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced enrollment of the 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.
The EnligHTN Renal Denervation System from St. Jude Medical. (Photo: Business Wire)
The EnligHTN II (Int Er nationa l non-randomized, s ingle-arm, lon g-term follow-up study of patients with uncontrolled Hyper Tensio N) trial expands upon the research conducted in the EnligHTN I trial, which demonstrated that patients with drug-resistant hypertension treated with the St. Jude Medical EnligHTN system had a rapid and sustained drop in blood pressure. After thirty days, systolic blood pressure was reduced by an average of 28 mmHg that remained stable with a reduction of 26 mmHg points six months after treatment, an important finding as the risk of cardiovascular death drops by half with every systolic decrease of 20 mmHg.
“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.”