First-in-Man CALM Trial Evaluates Vascular Dynamics' MobiusHD Implant for Resistant Hypertension

November 2, 2015—Malcolm T. Foster III, MD, presented interim results from the CALM (Controlling and Lowering Blood Pressure with the MobiusHD) first-in-man United States (CALM-FIM_US) and European (CALM-FIM_EUR) mirrored studies that are intended to assess the safety and preliminary efficacy of the MobiusHD implant (Vascular Dynamics, Inc.), which is designed to passively amplify pulsatile strain and reduce blood pressure (BP) through increased carotid sinus baroreceptor activation and enhanced sympathoinhibition. The studies are multicenter, open-label, and nonrandomized.

Dr. Foster presented the data during the first Late-Breaking Trials session at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

The MobiusHD system is delivered percutaneously to the carotid sinus using a novel rapid exchange catheter via a conventional 8-F guide catheter or 6-F sheath. The delivery system allows for partial deployment and recapture to optimize device positioning within the baroreceptor region. The incidence of serious adverse events, unanticipated adverse device effects, and changes in BP have been systematically collected over 3 years after study-device implantation in patients with stage 2 resistant hypertension (≥ 3 antihypertensive medications, of which one is a diuretic, and office systolic BP ≥ 160 mm Hg).

Dr. Foster reported that to date, 25 patients (taking an average of 4.2 antihypertensive medications at enrollment) have received treatment with MobiusHD, including nine patients who have been followed for 1 year or more. After implantation, 12 serious adverse events have been adequately managed and/or resolved. Average inclusion office-cuff BP was 182/106 mm Hg and average inclusion 24-hour ambulatory BP monitoring was 164/96 mm Hg. Fourteen patients reached the 180-day safety endpoint, with an average change in office-cuff BP of -23/-10 mm Hg and 24-hour ambulatory BP monitoring of -14/-8 mm Hg. The nine patients with 1-year follow-up demonstrated a sustained lowering in office cuff BP of -26/-16 mm Hg.

Enrollment continues across the CALM studies, and interim findings suggest MobiusHD appears safe and shows promising results in lowering BP in patients with stage 2 resistant hypertension, concluded Dr. Foster.