The European results of the first-in-human trial of Vascular Dynamics’ MobiusHD implant indicate that the device is associated with a reduction in 24-hour ambulatory systolic blood pressure of 21mmHg from baseline at six months after implantation in patients with resistant hypertension. The study was presented at the European Society of Cardiology (ESC) congress (26–30 August, Barcelona, Spain) and published in The Lancet.
The CALM-FIM_EUR study was a first-in-human feasibility study in which 30 patients were enrolled at six European centres between December 2013 and February 2016. All patients had resistant hypertension (defined as office systolic blood pressure above 160mmHg, 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 184/109mmHg at baseline and was reduced by 24/12mm Hg at six months. Mean baseline 24-hour ambulatory blood pressure was 166/100mmHg at baseline and was reduced by 21/12mmHg at six months despite an observed reduction in hypertensive medication. The investigators reported six serious adverse events, all of which were reported to have resolved without sequelae.
The MobiusHD System—a minimally-invasive system—is designed to capitalise on the ability of the body’s baroreceptor mechanism to regulate blood pressure. Baroreceptors are receptors located in the carotid artery that sense blood pressure and relay that information to the brain. The goal of the implant is to amplify the signals received by the surrounding arterial baroreceptors, and thereby increase the body’s natural response to lower blood pressure through vasodilation.
Lead author of the study, Wilko Spiering (University Medical Center Utrecht, the Netherlands) comments: “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. 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 USA, UK, and Germany shortly.”