Vascular Dynamics today released interim results from the 1st-in-human trial of its MobiusHD implant designed for treating resistant hypertension, touting a significant reduction in ambulatory systolic blood pressure at 6-months.
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.
Interim results from the Calm-FIM study indicated an average ambulatory systolic blood pressure reduction of more than 19 mmHg from baseline at 6 months. Data also indicated that 89% of the 42 patients in the trial had a greater than 10 mmHg drop in office systolic blood pressure or 5 mmHg or more in 24-hour ambulatory systolic blood pressure.
Other results also indicated a 16.3% reduction in use of antihypertensive medication, the Mountain View, Calif.-based company said.
“These data provide the backbone for our understanding of the enormous potential of this approach to managing resistant hypertension, which is the term for blood pressure that remains too high despite the use of as many as three or more antihypertensive drugs. The impressive results in an open label setting underscore the value of initiating the pivotal, sham-controlled trial to determine to what extent we can replicate, or even improve upon the outcomes,” US arm principal investigator Dr. Mark Bates of Charleston’s West Virginia University said in a press release.
Vascular Dynamics said it has also launched a pivotal, sham-controlled trial of the device in the US and Europe.
“We are encouraged with the results we’ve seen to date with the MobiusHD Calm-FIM studies in the US and the EU. Earlier this year the European arm results were published in The Lancet and we look forward to the publication of the combined data next year. We believe that this treatment represents a paradigm shift in treating resistant hypertension in the clinic and we look forward to continuing to generate data in the Calm 2 pivotal trial,” CEO Robert Stern said in a prepared statement.
In late August, Vascular Dynamics said the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension.
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