Vascular Dynamics said yesterday that it launched a pivotal trial of its MobiusHD device to treat high blood pressure ahead of a bid for a nod from the FDA.
The MobiusHD device is designed to help regulate blood pressure by reshaping the the carotid artery to stimulate baroreceptors and increase the body’s natural response to lower blood pressure through vasodilation. Mountain View, Calif.-based Vascular Dynamics said the Calm-2 study builds off of the results of its Calm-FIM trial; six-month results from that study showed an average ambulatory systolic blood pressure reduction of more than 19 mmHg from baseline at 6 months for patients treated with the MobiusHD device.
The new, 300-patient Calm-2 trial is a prospective, randomized, sham-controlled, double-blinded study of patients with drug-resistant hypertension.
“We are putting the right team and processes in place to successfully complete this landmark trial and to develop compelling clinical evidence to support future FDA approval,” president & CEO Ed Roschak said in prepared remarks
“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,” added co-principal investigator Dr. Bryan Williams of the University College London.
“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,” co-principal investigator Dr. Gregg Stone, of the NewYork-Presbyterian Hospital/Columbia University Medical Center, said in a press release.