FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device

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...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance vasculardynamics Source Type: news