St. Jude Medical, a medical device company based in Little Canada, on Monday announced that its EnligHTN renal denervation system safely and effectively lowered blood pressure at six months.
Renal denervation is a minimally invasive procedure to treat patients with drug-resistant hypertension – high blood pressure that does not respond adequately to medication.
The EnligHTN system targets nerves in the renal arteries leading to the kidneys. St. Jude is just one of many companies, including several local companies, working to control hypertension through the development and use of medical technology.
A typical normal blood pressure is below 120 systolic (the first number) and 80 diastolic (the second number) and is expressed as 120 / 80 mmHg.
Hypertension, or high blood pressure, is a blood pressure greater than 140 / 90 mmHg. The risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure, St. Jude said.
Patients enrolled in the EnligHTN I study had an average blood pressure of 176 / 96 mmHg 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 mmHg points after 30 days.
And, at six months:
- An average systolic blood pressure reduction of 26 mmHg points was maintained
- 76 percent of patients responded to the therapy and had an average office blood pressure of 150 / 86 mmHg
- There were no serious device- or therapy-specific adverse events reported
The EnligHTN I trial treated 46 patients whose blood pressure remained resistant despite being on three antihypertensive medications and a diuretic. To be considered for the study, St. Jude said, patients were required to have a systolic blood pressure greater than or equal to 160 mmHg – 150 mmHg for patients with type 2 diabetes.
The EnligHTN system is a multi-electrode ablation technology for renal denervation. An ablation catheter delivers radiofrequency (RF) energy to create tiny scars along the renal sympathetic nerves – a network of nerves that help control blood pressure. Disruption of the nerves has been found to cause systolic and diastolic blood pressure to drop.
The EnligHTN Renal Denervation System earned European CE Mark approval and has been launched in several overseas markets. It is not yet approved for use in the United States.