Enrollment Begins in CALM-2 Trial of Vascular Dynamics' MobiusHD System to Treat Drug-Resistant Hypertension
September 4, 2018—Vascular Dynamics, Inc. (VDI) announced enrollment of the first patients in the CALM-2 pivotal clinical trial, which is designed to establish safety and efficacy of the endovascular baroreceptor amplification (EVBA) procedure using the company's MobiusHD device as a treatment for drug-resistant hypertension.
CALM-2 (Controlling and Lowering Blood Pressure With MobiusHD) is a prospective, randomized, sham-controlled, double-blinded study. The trial is targeting enrollment of up to 300 patients at leading institutions across the United States and Europe.
According to the company, the MobiusHD is a flexible, self-expanding device that reshapes the carotid sinus after endovascular implantation. The technology is designed to use the natural blood pressure control of baroreceptors to address uncontrolled hypertension. It is intended to amplify the baroreflex while maintaining pulsatility. EVBA treatment with the MobiusHD system has received European CE Mark approval for the treatment of hypertension. It is not commercially available in the United States, where it is limited to investigational use only.
VDI advised that the first patients were enrolled in July 2018 at the Center for Clinical Research at Southern Illinois University Medicine in Springfield, Illinois, and The Lindner Research Center at The Christ Hospital Health Network in Cincinnati, Ohio.
Professor Bryan Williams, MD, who is Coprincipal Investigator of the trial, commented in VDI's announcement, “I am optimistic that device-based treatments, such as EVBA with the MobiusHD implant, may be able to provide effective solutions for patients who have not benefited from drug-based treatments.” Prof. Williams is Chair of Medicine at University College London, Director of Research at UCL Hospitals in London, United Kingdom. He is also Chairman-Elect of the European Council on Hypertension of the European Society of Cardiology.
Coprincipal Investigator Gregg Stone, MD, added, “Enrolling the first patients in the CALM-2 trial is an important step toward offering a new treatment option for this large patient population with resistant hypertension and the associated health risks.” Dr. Stone is Director of Cardiovascular Research and Education for NewYork-Presbyterian Hospital/Columbia University Medical Center in New York, New York, and Co-Director of Medical Research and Education at the Cardiovascular Research Foundation.