CALM-FIM Interim Data Presented for Vascular Dynamics' MobiusHD to Treat Resistant Hypertension
August 28, 2017—Vascular Dynamics, Inc. announced that interim results of the company’s first-in-human trial of its MobiusHD implant were presented in a podium presentation at the European Society of Cardiology's ESC Congress 2017, held August 26–30 in Barcelona, Spain.
The data showed an average reduction of ambulatory systolic blood pressure of 20 mm Hg from baseline in the first 40 patients (of an anticipated 50) to reach the 6-month endpoint in studies conducted in the United States and the European Union.
According to the company, these interim results of the CALM-FIM (Controlling and Lowering Blood Pressure with MobiusHD First-in-Man) trial, provided results from the first cohort of 40 patients evaluated in the United States (CALM-FIM US) and Europe (CALM-FIM EUR). The data demonstrated that at the 6-month evaluation point, 88% of the 40-patient cohort had a > 10-mm Hg drop in office systolic blood pressure or ≥ 5-mm Hg drop in 24-hour ambulatory systolic blood pressure. Many of these patients also experienced a reduction in their use of antihypertensive medication.
Study investigator Wilko Spiering, MD, who is President of the Dutch Hypertension Society presented the CALM-FIM data at ESC 2017. In the company's announcement, Dr. Spiering commented, "These interim data show significant promise in treating patients with resistant hypertension, that is, those who remain uncontrolled even after as many as three or more antihypertensive drugs. Our positive experience with the MobiusHD device demonstrates the need for continued investigation in a sham-controlled setting, which is currently running in the Netherlands and is starting up in the United States, United Kingdom, and Germany shortly."
Vascular Dynamics stated that the ESC presentation of these interim results will be followed by the publication of the final results of the CALM-FIM EU study in The Lancet on September 1, 2017.
The minimally invasive MobiusHD system 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.
The MobiusHD system has received CE Mark approval for the treatment of hypertension in the European Union. In the United States, the MobiusHD device is limited by law to investigational use only and is not commercially available, advised Vascular Dynamics.