Data from the first-in-human trial of its MobiusHD implant has shown an average reduction of ambulatory systolic blood pressure of 20 mmHg from baseline in the first 40 patients to reach the 6-month endpoint in studies conducted in the US and EU.
The MobiusHD implant is designed to amplify the signals received by the surrounding arterial baroreceptors, and thereby increase the body’s natural response to lower blood pressure through vasodilation.
Vascular Dynamics, Inc., (VDI), announced their interim results in a podium presentation at the European Society of Cardiology (ESC) in Barcelona, demonstrating that at the six-month evaluation point, 88 per cent of the 40-patient cohort had a greater than 10 mmHg drop in office systolic blood pressure or 5 mmHg or more in 24-hour ambulatory systolic blood pressure.
Many of these patients also reported to have experienced a reduction in their use of antihypertensive medication.
“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,” said Wilko Spiering, MD, internist-vascular medicine specialist, University Medical Center Utrecht, the Netherlands and President of the Dutch Hypertension Society.
“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.”
A study, due to be published in ‘The Lancet’ on September 1, 2017, will outline the final results of the CALM-FIM_EU study.
Hypertension, or elevated blood pressure, is a common medical condition that currently affects one billion people worldwide.
The American Heart Association (AHA) estimates that high blood pressure costs the U.S. $46 billion each year, including the cost of healthcare services, medications to treat high blood pressure, and lost productivity.