St. Jude Medical, Inc. has gained U.S. FDA approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.
The other day someone posed the question about when St.Jude would get its EnligHTN renal denervation system into a US trial. Well, coincidentally, that time is now.
Renal denervation, the minimally invasive therapy that may provide a lasting reduction in blood pressure for patients with hypertension who are resistant to medications, is developing a wall of supportive clinical data. There are few if any who argue that the technique of zapping nerves along the renal arteries leading to the kidneys causes a sustained decrease in systolic and diastolic blood pressure.
St.Jude is among the first into the game, along with a handful of others who are chasing down Medtronic’s Symplicity offering with a veritable tonne of clinical data supporting their various offerings.
EnligHTN IV study is a randomized, single-blind, controlled, multi-center trial, which St.Jude will hope demonstrates the safety and effectiveness of the EnligHTN Renal Denervation System in reducing systolic blood pressure when measured in an office setting. The study will enroll approximately 590 patients between the ages of 18 and 80 with an office systolic blood pressure of 160 mmHg or greater, who are taking three or more antihypertensive medications including a diuretic. Study patients will be enrolled at up to 80 sites in the U.S. and Canada.
As the name suggests, EnligHTN IV follows I, II and III, which are variously underway in Australia, New Zealand and Europe. The biggest of them all, grandly tagged the EnligHTNment trial, is the largest randomized, prospective clinical study ever conducted for renal denervation. The study is evaluating the long-term effects of using the EnligHTN system in patients with uncontrolled hypertension to study if there is also a reduction in risk of major cardiovascular events such as heart attack, stroke, heart failure hospitalizations and cardiovascular death. Approximately 4,000 patients are being enrolled around the world at up to 150 sites.
No renal denervation system is yet available in the United States, an incredible fact when one considers their ready availability in Europe and the already weighty clinical pedigree.
“Researching the treatment of hypertension is one example of the ongoing investments St. Jude Medical is making to deliver high-quality, innovative products, such as the EnligHTN Renal Denervation System, which aim to reduce health care costs and improve patient outcomes,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “The EnligHTN IV study represents another important step in our commitment to advancing science, technology and clinical evidence that supports renal denervation for the millions of patients who live with uncontrolled high blood pressure.”
Source: St. Jude Medical, Inc.