21 Aug CALM Study Launches Trial of MobiusHD Carotid Implant For Resistant Hypertension
MedicalResearch.com Interview with:
Gregg W. Stone MD
Professor of Medicine
Director of Cardiovascular Research and Education
Center for Interventional Vascular Therapy
New York Presbyterian Hospital/ Columbia University Medical Center
Co-Director of Medical Research and Education
The Cardiovascular Research Foundation
New York, NY
MedicalResearch.com: How does the MobiusHD system work?
Response: The MobiusHD System is a thin stent-like device which is implanted during a minimally invasive procedure into the carotid artery. The MobiusHD modifies the activity of baroreceptors located in the carotid artery, increasing arterial vasodilation to reduce blood pressure.
MedicalResearch.com: What is the background for this study? What is the MobiusHD device designed to do?
Response: Hypertension (often defined as an office blood pressure ≥140/90mmHg) is a leading cause of premature death. Elevated blood pressure (BP) contributes to 62% of all strokes and 49% of all cases of heart disease, culminating in an estimated 7.1 million deaths per year, representing 14% of all deaths world-wide. Hypertension affects almost one third of adults and more than 1 billion adults globally. The prevalence of hypertension is increasing as the population ages, typically affecting over 50% of people aged over 60 years.
While hypertension can be controlled in the majority of patients with lifestyle changes and drug therapy, up to 10% of patients the blood pressure cannot be controlled despite treatment with three of more medications. This is known as resistant hypertension. These patients have a very poor prognosis, with high rates of stroke and cardiovascular disease. The first application for the MobiusHD will be in patients with resistant hypertension.
In the CALM-FIM study, 40 patients with resistant hypertension were treated with the MobiusHD device, and had substantial reductions in blood pressure without major safety concerns. Based on this study, we have designed a pivotal trial of the MobiusHD implant for the treatment of resistant hypertension. The CALM (Controlling and Lowering Blood Pressure with MobiusHD) 2 trial is a multicenter, prospective, randomized, double-blind, sham-controlled study which will evaluate the safety and effectiveness of the MobiusHD System, and is designed to support US regulatory approval. Approximately 300 patients will be enrolled at up to 45 institutions in the US and Europe. The primary effectiveness endpoint is the change in mean 24-hour ambulatory blood pressure from baseline to 6 months.
MedicalResearch.com: How frequent is triple-antihypertension-medication resistant high blood pressure?
Response: Resistant hypertension is defined as a mean 24-hour ambulatory systolic blood pressure ≥145 mmHg and ≤200 mmHg on a stable medical regimen for at least 8 weeks of at least 3 maximally tolerated guideline directed (JNC8) anti-hypertensive drugs, including an “A+C+D” antihypertensive medication regimen, where “A” is an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, “C” is a calcium channel blocker, and “D” is a diuretic. Despite such therapy, the blood pressure of ~5-10% of all patients with hypertension remains uncontrolled.
MedicalResearch.com: What should readers take away from your report?
Response: In clinical practice, we are too commonly faced with hypertension patients who do not respond to medication or lifestyle changes. The MobiusHD system may be an important treatment option for such patients. We are initiating a pivotal clinical trial that is appropriately designed to determine whether the MobiusHD system is safe and effective for such patients.
MedicalResearch.com: Is there anything else you would like to add?
Response: I am the co-principal investigator of the CALM 2 trial and a consultant to Vascular Dynamics, the manufacturer of the MobiusHD system and the sponsor of the trial.
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