Vascular Dynamics, Inc., a privately held medical device company developing novel solutions for the treatment of hypertension, will present updated interim results of the company’s first-in-human trial of its MobiusHD® implant today at the TCT conference in Denver. The data showed an average reduction of ambulatory systolic blood pressure of more than 19 mmHg from baseline at the 6-month endpoint in studies conducted in the US and EU.
These interim results of the CALM-FIM (Controlling and Lowering Blood Pressure with MobiusHD First in Man) trial will be outlined today during a didactic session. The data, which were updated from a previous presentation at the European Society of Cardiology conference in August to include data from the United States arm of the Study, demonstrated 89 percent of the 42-patients combined European and United States cohort at six-months had a greater than 10 mmHg drop in office systolic blood pressure or 5 mmHg or more in 24-hour ambulatory systolic blood pressure. In addition, these patients experienced an average of 16.3 percent reduction in their use of antihypertensive medication. Since that time, Vascular Dynamics has initiated its pivotal, sham-controlled trial, CALM 2, in both the United States and Europe.
“These data provide the backbone for our understanding of the enormous potential of this approach to managing resistant hypertension, which is the term for blood pressure that remains too high despite the use of as many as three or more antihypertensive drugs,” said Mark Bates, MD, professor of medicine and surgery, West Virginia University, Charleston, WV, who will present the data at TCT and is the principal investigator of the US arm of the CALM-FIM study. “The impressive results in an open label setting underscore the value of initiating the pivotal, sham-controlled trial to determine to what extent we can replicate, or even improve upon the outcomes.”
“We are encouraged with the results we’ve seen to date with the MobiusHD CALM-FIM studies in the US and the EU. Earlier this year the European arm results were published in The Lancet and we look forward to the publication of the combined data next year,” said Robert Stern, CEO of Vascular Dynamics.1 “We believe that this treatment represents a paradigm shift in treating resistant hypertension in the clinic and we look forward to continuing to generate data in the CALM 2 pivotal trial.”