Vascular Dynamics has revealed that enrolment of the first patients in an FDA-approved and best-in-class pivotal clinical trial has started. The CALM-2 study is designed to establish safety and efficacy of the novel endovascular baroreceptor amplification (EVBA) procedure using the unique MobiusHD device as a treatment for drug resistant hypertension.
A press release reports that Vascular Dynamics is developing the first minimally-invasive technology designed to use this natural blood pressure control system to address uncontrolled hypertension. It adds that the MobiusHD is a flexible, self-expanding device that reshapes the carotid sinus following endovascular implantation. It is intended to amplify the baroreflex while maintaining pulsatility.
Results published in The Lancet, from an open-label, proof-of-concept trial (CALM-FIM) using the EVBA approach to treat patients with resistant hypertension were positive—showing significant reductions in blood pressure through six months, greater than the 24-hour ambulatory blood pressure reductions reported to date for alternative devices used to treat hypertension. These results led to the design and development of a rigorous pivotal clinical trial intended to generate conclusive evidence confirming the safety and efficacy of this unique device for resistant hypertension patients.
The CALM-2 (Controlling and lowering blood pressure with MobiusHD) pivotal trial is a prospective, randomised, sham-controlled, double-blinded study targeting patients with drug-resistant hypertension. Lessons learned from numerous clinical trials of first-generation device-based approaches to hypertension were incorporated into the CALM-2 study protocol to provide a best-in-class clinical trial design. The CALM-2 trial is targeting enrolment of up to 300 patients at leading institutions across the USA and Europe. The first patients were enrolled in July 2018 at the Center for Clinical Research at Southern Illinois University Medicine and The Lindner Research Center at The Christ Hospital Health Network.
Gregg Stone (Columbia University Medical Center/New York-Presbyterian Hospital, New York, USA), co-principal investigator of the CALM-2 trial, comments: “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.”
Bryan Williams (University College London, London, UK), who is the co-principal investigator of the trial and chair-elect of the European Council on Hypertension of the European Society of Cardiology, comments: “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.resist