Data Published in The Lancet Shows Positive Results at Primary Endpoint in the Treatment of Resistant Hypertension with MobiusHD Device

Publication Follows Positive Interim Results in US and EU Patients Presented at the European Society of Cardiology Conference

MOUNTAIN VIEW, Calif., Sept.  01, 2017  (GLOBE NEWSWIRE) -- Vascular Dynamics, Inc. (VDI), a privately held medical device company developing novel solutions for the treatment of hypertension, today announced European results of the company's first-in-human trial of its MobiusHD^® implant published in The Lancet.  The publication reported an average reduction of 24-hour ambulatory systolic blood pressure of 21 mmHg from baseline in the 30 European patients 6 months after implantation. Moreover, the Study authors reported that implantation of the MobiusHD device was straightforward for experienced interventionists, with a 100 percent procedural success rate.

The Lancet publication, which was posted today online, noted that the CALM-FIM_EUR study was a first-in-human feasibility study in which 30 patients were enrolled at 6 European centers in the Netherlands (5) and Germany (1) between December 2013 and February 2016.  All patients had resistant hypertension, defined as office systolic blood pressure above 160 mmHg, despite the use of three or more antihypertensives, including a diuretic. The MobiusHD devices were implanted unilaterally in the internal carotid artery. Mean office blood pressure was 184/109 mmHg at baseline and was reduced by 24/12 mm Hg at 6 months. Mean baseline 24-hr ambulatory blood pressure was 166/100 mmHg at baseline and was reduced by 21/12 mmHg at 6 months despite an observed reduction in hypertensive medication. The investigators reported 6 serious adverse events, all of which were reported to have resolved without sequelae.

"These published results of the CALM-FIM_EUR study demonstrate that the MobiusHD device may significantly reduce both office and ambulatory blood pressure among patients on three or more drugs who have been unable to control their hypertension," said Wilko Spiering, MD, internist-vascular medicine specialist, University Medical Center Utrecht, the Netherlands and President of the Dutch Hypertension Society, lead author of the study. "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."