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


Vascular DynamicsVascular 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.

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DeviceTalks West: Expertise you need to know

textadimage Medical device suppliers are light years away from the days when they merely filled orders to spec for medtech OEMs – as a visit to the upcoming DeviceTalks West will quickly confirm.

From incorporating steerability into catheters to getting validation and testing done right, the companies serving the medical device industry have become specialized experts in their own right.

Read on to discover five example of medical device expertise to be had at DeviceTalks West, which runs Dec. 11–12 in Orange County, Calif.

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