Vascular Dynamics said today that the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension.
MobiusHD is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors there.
Mountain View, Calif.–based Vascular Dynamics said the 300-patient Calm 2 study is designed to compare treatment with MobiusHD and a sham procedure. The primary safety endpoint is a composite of death, myocardial infarction, stroke, device embolization, carotid occlusion, new ipsilateral carotid stenosis requiring surgical or percutaneous intervention, or Bleeding Academic Research Consortium 3 or 5 bleeding events at 90 days. The primary effectiveness endpoint is change in mean 24-hour ambulatory systolic blood pressure at 180 days, according to ClinicalTrials.gov.
Calm 2 is slated to start in September, with a final data collection for the primary outcomes due in May 2020. Vascular Solutions said it’s also participating in the FDA’s expedited access program and is one of nine companies enrolled in the agency’s early feasibility study IDE pilot program.
“Initiating the Calm 2 trial is an important milestone for Vascular Dynamics, as it allows us the opportunity to demonstrate the potential utility of our technology in a significant patient population,” president & CEO Robert Stern said in prepared remarks. “With our participation in both the EAP and IDE programs, we also have the unique opportunity to work closely with the FDA to ensure a more rapid start to the trial while still maintaining the high standards of safety, efficacy and scientific validity required by the program.”
“The rigor and scientific focus of the Calm 2 trial has been crafted and improved from much of what we learned from prior studies. Calm 2 will offer patients a therapeutic alternative and a level of medical monitoring to which they otherwise would never have access outside of a clinical trial,” added co-prinicipal investigator Dr. Bryan Williams of the University College London.
“In clinical practice, we are regularly faced with those hypertension patients who simply do not respond to medication or lifestyle changes. Initiating this trial is an important step toward identifying additional viable treatments to help this large population of patients,” co-principal investigator Dr. Gregg Stone, of New York City’s Columbia University Medical Center/New York-Presbyterian Hospital, said in a press release.
Vascular Dynamics in March closed a private placement worth $10.4 million that it plans to use on the clinical program for the MobiusHD device.