Vascular Dynamics' MobiusHD System Receives CE Mark for the Treatment of Resistant Hypertension

January 6, 2016—Vascular Dynamics, Inc. announced receipt of European CE Mark approval for its minimally invasive MobiusHD system for the treatment of resistant hypertension. The MobiusHD system is a passive implant delivered using standard percutaneous technique. In the United States, the MobiusHD is an investigational device limited by federal law to investigational use only, advised Vascular Dynamics.

According to Vascular Dynamics, the MobiusHD system capitalizes on the ability of the body’s baroreceptor mechanism to regulate blood pressure. The MobiusHD implant is designed to amplify the signals received by the surrounding arterial baroreceptors in the wall of the carotid sinus and thereby amplify the body’s natural response to lower blood pressure through vasodilation. Blood pressure is reduced because the increase in baroreceptor signaling results in a commensurate reduction in blood pressure.

In the company’s press release, Wilko Spiering, MD, of UMC Utrecht in the Netherlands, commented, “Options for patients to reduce their blood pressure are limited once they have failed multidrug therapy. We have seen very good results in the patients we have treated at our center in the first-in-human clinical trial with the MobiusHD barostenting procedure.”

Dr. Spiering, who serves as President of the Dutch Society of Vascular Internists and Secretary of the Dutch Society of Hypertension, continued, “We are very excited about the new MobiusHD barostenting procedure and look forward to being able to provide it to our patients who have limited treatment options. Our team looks forward to working with the Vascular Dynamics team to accelerate the clinical process with the next round of studies in the European Union.”

Gregg W. Stone, MD, Director of Cardiovascular Research and Education at Columbia University Medical Center/New York Presbyterian Hospital, will be co-chair of the upcoming Vascular Dynamics’ MobiusHD International pivotal study. Dr. Stone stated in the announcement, “I’ve seen numerous approaches to controlling resistant hypertension over the years. Most drugs have side effects leading to poor compliance, and more invasive approaches have other drawbacks.”

Dr. Stone added, “The MobiusHD is a simple, passive implant that is designed to reduce blood pressure while preserving the body’s natural ability to modulate blood pressure. The minimally invasive MobiusHD barostenting procedure could be life changing for this patient population while also reducing the cost of health care.”

Vascular Dynamics is conducting the prospective, open-label, controlled, multicenter CALM (Controlling and Lowering Blood Pressure With the MobiusHD) first-in-man European (CALM-FIM_EUR) and United States (CALM-FIM_US) trials with the primary endpoint of safety at 6 months following the procedure. There are now eight active centers in the United States and 13 centers in the European Union that are open for recruitment.

Patients enrolled in the study have a systolic blood pressure of 160 mm Hg or greater and are taking three or more prescription antihypertensives medicines, including a diuretic. Patients are prescreened with Doppler ultrasound and coronary computed tomographic angiography or magnetic resonance angiography. 

Malcolm T. Foster III, MD, presented interim CALM results during the first Late-Breaking Trials session at VIVA 15, the 13th annual Vascular InterVentional Advances meeting, which was held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada.