Vascular Dynamics yesterday released interim results from the 1st-in-human trial of its MobiusHD implant designed for treating resistant hypertension, touting significant reductions in ambulatory systolic blood pressure.
Results were released at the European Society of Cardiology’s annual meeting in Barcelona.
The MobiusHD device is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors and increase the body’s natural response to lower blood pressure through vasodilation.
Data in the interim study came from the 1st 40 patients to reach the 6-month endpoint, indicating that 88% of the cohort had a greater than 10 mmHg drop in systolic blood pressure or 5 mmHg or more in 24-hour ambulatory systolic blood pressure. The average reduction of ambulatory systolic blood pressure was reported at 20 mmHg, the company said.
Interim results will be followed by a study which is slated to be published in The Lancet next month, Vascular Dynamics said.
“These interim data show significant promise in treating patients with resistant hypertension, that is, those who remain uncontrolled even after as many as three or more antihypertensive drugs. Our positive experience with the MobiusHD device demonstrates the need for continued investigation in a sham-controlled setting, which is currently running in the Netherlands and is starting up in the United States, United Kingdom, and Germany shortly,” trial investigator Dr. Wilko Spiering of the Netherlands’ University Medical Center Utrecht said in a press release.
Earlier this month, Vascular Dynamics said the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension.