CALM-2 Trial Approved for Vascular Dynamics' MobiusHD System to Treat Resistant Hypertension
August 15, 2017—Vascular Dynamics, Inc. announced that the US Food and Drug Administration (FDA) has approved the company’s investigational device exemption (IDE) application to initiate the pivotal trial for its MobiusHD system for the treatment of resistant hypertension. The CALM-2 (Controlling and Lowering Blood Pressure with MobiusHD) trial is a multicenter, prospective, randomized, double-blind, sham-controlled pivotal study designed to evaluate the safety and effectiveness of the MobiusHD device.
The study will evaluate patients from select locations throughout the United States whose hypertension remains uncontrolled despite using three or more antihypertensive pharmacologic therapies. Vascular Dynamics also intends to conduct the CALM-2 trial in certain European countries after receiving appropriate regulatory authorization.
According to the company, the minimally invasive MobiusHD system capitalizes on the ability of the body’s baroreceptor mechanism to regulate blood pressure. The implant is designed to amplify the signals received by the surrounding arterial baroreceptors, and thereby increase the body’s natural response to lower blood pressure through vasodilation. In the United States, the MobiusHD device is limited by law to investigational use only, advised the company.
Gregg Stone, MD, and Professor Bryan Williams, MD, are Co-Principal Investigators of the CALM-2 trial.
In the company's announcement, Prof. Williams commented, "The rigor and scientific focus of the Calm-2 trial has been crafted and improved from much of what we learned from prior studies. Calm-2 will offer patients a therapeutic alternative and a level of medical monitoring to which they otherwise would never have access outside of a clinical trial." Prof. Williams is Chair of Medicine at University College London and Director of the NIHR UCLH/UCL Biomedical Research Centre and Director of Research at UCL Hospitals in London, United Kingdom. He is Chairman-Elect of the European Council on Hypertension of the European Society of Cardiology.
Dr. Stone added, “In clinical practice, we are regularly faced with those hypertension patients who simply do not respond to medication or lifestyle changes. Initiating this trial is an important step toward identifying additional viable treatments to help this large population of patients,” Dr. Stone is Director of Cardiovascular Research and Education for Columbia University Medical Center/New York-Presbyterian Hospital in New York, New York, and Co-Director of Medical Research and Education at the Cardiovascular Research Foundation.
Vascular Dynamics noted that the company has been chosen as a participant in the FDA’s Expedited Access Pathway program, a focused initiative to significantly accelerate access for patients and their physicians to innovative medical treatments. Vascular Dynamics is also one of nine companies chosen for the FDA’s Early Feasibility Study IDE Pilot Program, which enables companies to conduct smaller-scale studies under the guidance of the agency in the United States to meet the requirements for an earlier pathway toward approval.