First in human trial of Mobius HD implant to treat resistant hypertension published in The Lancet-Vascular Dynamics.

Vascular Dynamics announced European results of the company�s first-in-human trial of its Mobius HD implant in resistant hypertension has been 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 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.

See- "Endovascular baroreflex amplification for resistant hypertension: a safety and proof-of-principle clinical study"- Dr Wilko Spiering, MD,Prof Bryan Williams, MD, Jan Van der Heyden, MD, et al., for the show CALM-FIM_EUR investigators -Published: 01 September 201 DOI: http://dx.doi.org/10.1016/S0140-6736(17)32337-1.