CVRx presented its first available two-year data from the European clinical trial evaluating the Rheos hypertension (HT) system, an implantable medical device designed to control hypertension, at 2008 Hypertension Berlin meeting in Germany last week.
The Rheos HT System could provide a new treatment option for the millions of people who cannot control their HT with medications. The device activates the body’s own system for regulating blood pressure, according to the Minneapolis-based CVRx.
“The early data on improved heart function and preserved kidney function also presented at this conference are encouraging, and we are hopeful Rheos HT Therapy may help prevent serious, costly conditions related to hypertension,” said Nadim Yared, CVRx president and CEO.
The clinical data from the Device-Based Therapy of Hypertension (DEBuT-HT) study were presented on the 45 patients enrolled in the study. Of these patients, 16 four European centers have completed two years of Rheos HT therapy.
The researchers said that blood pressure measurements were taken in the clinic and after two years showed:
- Systolic blood pressure was reduced by an average of 35 mmHg (191 vs.156 mmHg); and
- Diastolic blood pressure was reduced by an average of 24 mmHg (116 vs. 92 mmHg).
The researchers found similar results at three months and one year of Rheos HT Therapy. Patients remained on background medical therapy during the trial.
During the two-year study period, the average number of antihypertensive medications remained stable, CVRx reported.
A drop in systolic blood pressure of at least 20 mmHg was achieved in 12 of the 16 patients (75 percent), according to the company researchers. The Rheos implants were well tolerated, and there were no unanticipated adverse events related to the system or procedure.